SERENA CRT-P MRI SURESCAN Model W1TR02

Transcription

1 SERENA CRT-P MRI SURESCAN Model W1TR02 Hert Filure Mngement Report This report provides n overview of the ptient s condition over the short nd long term, with focus on hert filure mngement. The report includes grphs tht show OptiVol 2.0 fluid trends nd trends relted to hert filure over the lst 14 months. Physicl chrcteristics Volume 19.9 cm 3 Mss 30 g H x W x D 59 mm x 46.5 mm x 11 mm Rdiopque ID c RNP Surfce re of titnium device cn 34.8 cm 2 Mterils in contct with humn tissue d Bttery Titnium, polyurethne, silicone ruer Lithium-hyrid CFx silver vndium oxide Volume with connector holes unplugged. Grommets my protrude slightly eyond the cn surfce. c The rdiopque ID, which includes Medtronic-identifier symol, cn e viewed in fluoroscopic imge of the device. d These mterils hve een successfully tested for the ility to void iologicl incomptiility. The device does not produce n injurious temperture in the surrounding tissue during norml opertion. Replcement indictors Recommended Replcement Time (RRT) Elective Replcement Indictor (ERI) End of Service (EOS) 180 dys fter 3 consecutive dily utomtic mesurements of 2.63 V or immeditely fter 3 consecutive dily utomtic mesurements of 2.60 V, whichever comes first 3 months fter RRT 3 months fter ERI MR Conditionl with SureScn Technology Bluetooth Wireless Telemetry* AdptivCRT Algorithm CrdioSync Optimiztion OptiVol 2.0 Fluid Sttus Monitoring MVP Mode Complete Cpture Mngement Dignostic (ACM, RVCM, LVCM) * Bluetooth enled CreLink remote monitors will e ville pending FDA sumission nd pprovl.

2 Tchyrrhythmi detection prmeters Tchyrrhythmi detection prmeters AT/AF Detection Zones 1 ; 2 On; Monitor AT/AF Intervl (Rte) 150; ms Fst AT/AF Intervl (Rte) 150; ms VT Monitor Monitor ; Off VT Monitor Intervl (Rte) 280; ms 0.45; 0.60 mv (± 50%); 0.90; 1.20; 2.00; 2.80; 4.00; 5.60; 8.00; mv RV Sensitivity (± 30%) Bipolr: 0.9 mv Unipolr: 2.80 mv 0.15 mv (± 75%); 0.30; 0.45; 0.60 mv (± 50%); 0.90; 1.20; 1.5; 1.8; 2.1; 4.0 mv Atril Sensitivity c (± 30%); Off Bipolr: 0.3 mv Unipolr: 0.45 mv The mesured intervls re truncted to 10 ms multiple (for exmple, 457 ms ecomes 450 ms). The device uses this truncted intervl vlue when pplying the progrmmed criteri nd clculting intervl verges. The device complies with the requirements of ISO when the sensitivity threshold is progrmmed to 2.0 mv or higher. c The device complies with the requirements of ISO when the sensitivity threshold is progrmmed to 1.8 mv or higher. Atril tchyrrhythmi therpy prmeters Antitchy Pcing (ATP) Fst AT/AF Rx Sttus Therpy Type Rmp; Burst+ Rx1: Rmp ; Rx2: Burst+ ; Rx3: Rmp AT/AF Rx Sttus Therpy Type Rmp; Burst+ Rx1: Rmp ; Rx2: Burst+ ; Rx3: Rmp Burst+ prmeters Initil # S1 Pulses 1; 2; ; 20; 25 A-S1 Intervl (%AA) 28; 31; 34; 38; 41 59; 63; 66; ; 88; 91; 94; 97% S1-S2 (%AA) 28; 31; 34; 38; 41 59; 63; 66; ; 84; 88; 91; 94; 97%; Off S2-S3 Decrement 0; 10; ms; Off Intervl Decrement 0; 10 ; 20; 30; 40 ms # Sequences 1; 2; 3 10 Rmp prmeters Initil # S1 Pulses 1; 2; 3 13 ; 14; 15; 20; 25 A-S1 Intervl (%AA) Rx1 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97% Rx2 28; 31; 34; 38; 41 59; 63; 66 84; 88; 91 ; 94; 97% Rx3 28; 31; 34; 38; 41 59; 63; ; 84; 88; 91; 94; 97% Intervl Decrement 0; ms # Sequences 1; 2 8; 9; 10 Stop Atril Rx fter (Shred) Rx/Led Suspect Disle Atril ATP if it ccelertes V. rte? Yes ; No Disle ll tril therpies if tril led position is suspect? (Atril Led Position Check) Yes ; No Durtion to stop 12; 24; 48 ; 72 hr; None Episode Durtion efore Rx Delivery Episode Durtion efore ATP 0; 1 ; 2 5; 7; 10; 15; 20; 25; 30; 40; 50 min; 1; 2; 3; 4; 5; 6; 12; 24 hr Rective ATP Rhythm Chnge On ; Off Time Intervl Off ; 2; 4; 7; 12; 24; 36; 48 hr Shred A. ATP A-A Minimum 100; ms ATP Intervl (± 6 ms) A. Pcing Amplitude 1; 2 V (+0.5 V/-33%) 3; 4; 5; 6 ; 8 V (+20%/-33%) A. Pcing Pulse Width 0.1; ms (± 25 μs) VVI Bckup Pcing Off; On (Alwys); On (Auto-Enle) VVI Bckup Pcing Rte 60; pm The mesured intervls re truncted to 10 ms multiple (for exmple, 457 ms ecomes 450 ms). The device uses this truncted intervl vlue when pplying the progrmmed criteri nd clculting intervl verges. Pcing s Modes, rtes, nd intervls Mode DDDR; DDD ; AAIR<=>DDDR; AAI<=>DDD; DDIR; DDI; AAIR; AAI; VVIR; VVI; DOO; AOO; VOO; ODO Mode Switch On ; Off Lower Rte 30; ; 70; pm (± 2 pm) Upper Trcking Rte 80; pm (± 2 pm); 180; pm (+2/-11 pm) Pced AV 30; ms (± 4 ms) Sensed AV 30; ms (+30; 2 ms) Mximum AV Intervl Limit Off ; 250; ms

3 Modes, rtes, nd intervls, cont d. PVARP Auto ; 150; ms (+5; 30 ms) Minimum PVARP A. Refrctory Period 150; ms (+5; 30 ms) 150; ms (+5; 30 ms) The corresponding Lower Rte intervl cn e clculted s follows: Lower Rte intervl (ms) = 60,000/Lower Rte. If CRT is dptive, Pced AV nd Sensed AV cnnot e selected or progrmmed. Atril prmeters Atril Amplitude 0.5; V ( V/-33%) ; 5.5; 6; 8 V (+15%/-33%) Atril Pulse Width 0.03; 0.06 ms (± 10 μs); 0.1; 0.2; 0.3; ms (± 25 μs) Atril Sensitivity Off; 0.15; 0.3; 0.45; 0.6 mv (± 60%); 0.9; 1.2; 1.5; 1.8; 2.1; 4.0 mv (± 40%) Unipolr: 0.45 mv Bipolr: 0.3 mv Atril Pce Polrity Bipolr; Unipolr Atril Sense Polrity Bipolr; Unipolr Atril Led Monitor Monitor Only; Adptive Min Limit 200 ; 300; 400; 500 Ω Mx Limit 1,000; 1,500; 2,000; 3,000 Ω When Atril Amplitude is 8 V, Atril Pulse Width must e less thn 1.3 ms. RV prmeters RV Amplitude 0.5; V ( V/-33%) ; 5.5; 6; 8 V (+15%/-33%) RV Pulse Width 0.03; 0.06 ms (±10 μs); 0.1; 0.2; 0.3; ms (± 25 μs) 0.45; 0.60; 0.90; 1.20; 2.00; 2.80; 4.00; 5.60; 8.00; mv RV Sensitivity (±55%) Unipolr: 2.80 mv Bipolr: 0.90 mv RV Pce Polrity Bipolr; Unipolr RV Sense Polrity Bipolr; Unipolr RV Led Monitor Monitor Only; Adptive Min Limit 200 ; 300; 400; 500 Ω Mx Limit 1,000; 1,500; 2,000; 3,000 Ω When RV Amplitude is 8 V, RV Pulse Width must e less thn 1.3 ms. LV prmeters LV Amplitude 0.5; V ( V/-33%) ; 5.5; 6; 8 V (+15% -33%) LV Pulse Width 0.03; 0.06 ms (±10 μs); 0.1; 0.2; 0.3; ms (± 25 μs) LV Pce Polrity LVtip to RVring; LVtip to Cn; LVring to RVring; LVring to Cn; LVtip to LVring LV Led Monitor Monitor Only; Adptive Min Limit 200 ; 300; 400; 500 Ω Mx Limit 1,000; 1,500; 2,000; 3,000 Ω When LV Amplitude is 8 V, LV Pulse Width must e less thn 1.3 ms. CRT pcing prmeters AdptivCRT Adptive Bi-V nd LV ; Adptive Bi-V; Nondptive CRT V. Pcing RV; RV LV; LV RV V-V Pce Dely Auto ; 0; ms V. Sense Response On ; Off Mximum Rte 95; pm Atril Trcking Recovery On ; Off If CRT is dptive, V. Pcing cnnot e selected or progrmmed. Atril Cpture Mngement prmeters Atril Cpture Mngement Adptive ; Monitor; Off Atril Amplitude Sfety Mrgin 1.5x; 2.0x ; 2.5x; 3.0x Atril Minimum Adpted Amplitude 1.0; 1.5 ; 2.0; 2.5; 3.0; 3.5 V Atril Acute Phse Remining Off; 30; 60; 90; 120 ; 150 dys RV Cpture Mngement prmeters RV Cpture Mngement Adptive ; Monitor; Off RV Amplitude Sfety Mrgin 1.5x; 2.0x ; 2.5x; 3.0x RV Minimum Adpted Amplitude 1.0; 1.5; 2.0 ; 2.5; 3.0; 3.5 V RV Acute Phse Remining Off; 30; 60; 90; 120 ; 150 dys LV Cpture Mngement prmeters LV Cpture Mngement Adptive ; Monitor; Off +Auto ; +0.5; +1.0; +1.5; LV Amplitude Sfety Mrgin +2.0; +2.5 V LV Mximum Adpted 0.5; ; 5.5; 6 V Amplitude

4 Blnking periods PVAB Intervl 10 ; ; 110; ms PVAB Method Prtil ; Prtil+; Asolute A. Blnk Post AP 150; ms (± 5 ms) A. Blnk Post AS 100 ; ms (± 2 ms) V. Blnk Post VP 150; ms (± 5 ms) 120 ; ; 200; 220; V. Blnk Post VS 250; 280; 300; 320 ms (±2 ms) If the PVAB Method is set to Prtil, the minimum selectle vlue for the PVAB Intervl is 100 ms. Rte response pcing prmeters Rtes ADL Rte 60; pm (± 2 pm) Upper Sensor 80; pm (± 2 pm) Rte Profile Optimiztion On ; Off Adjust Rte Response ADL Response 1; 2; 3 ; 4; 5 Exertion Response 1; 2; 3 ; 4; 5 Additionl s Activity Threshold Low ; Medium Low; Medium High; High Activity Accelertion 15; 30 ; 60 s Activity Decelertion Exercise ; 2.5; 5; 10 min ADL Set Point 5; 6 40; UR Set Point 15; 16 40; 42 80; Rte dptive AV prmeters Rte Adptive AV On ; Off Strt Rte 50; pm Stop Rte 55; pm Minimum Pced AV 30; ms Minimum Sensed AV 30; ms If CRT is dptive, Rte Adptive AV cnnot e selected or progrmmed. Atril rte stiliztion prmeters A. Rte Stiliztion Mximum Rte 80; pm Intervl Percentge Increment 12.5; 25 ; 50% Atril Preference Pcing prmeters A. Preference Pcing Mximum Rte 80; pm Intervl Decrement 30 ; 40; ; 150 ms Serch Bets 5; 10; 15; 20 25; 50 Post Mode Switch Overdrive Pcing (PMOP) prmeters Post Mode Switch Overdrive Rte 70; 75; pm Overdrive Durtion 0.5; 1; 2; 3; 5 ; 10; 20; 30; 60; 90; 120 min Conducted AF response prmeters Conducted AF Response On ; Off Response Level Low; Medium ; High Mximum Rte 80; pm Ventriculr rte stiliztion prmeters V. Rte Stiliztion Mximum Rte 80; 85; pm Intervl Increment 100; ms Rte drop response prmeters Rte drop response Detection Type Drop ; Low Rte; Both Drop Detection Drop Size 10; pm Drop Rte 30; pm Detection Window 10; 15; 20; 25; 30 s 1 ; 1.5; 2; 2.5 min Low Rte Detection Detection Bets 1; 2; 3 ets Intervention Intervention Rte 70; pm Intervention Durtion 1; 2 15 min When Rte Drop Response is set to On, the lower rte is utomticlly set to 45 pm. Sleep prmeters Sleep Sleep Rte Bed Time Wke Time 30; ; 55; 60; 70; pm 00:00; 00:10 22:00 23:50 00:00; 00:10 07:00 23:50

5 Non-competitive tril pcing (NCAP) prmeters Non-Comp Atril Pcing On ; Off NCAP Intervl 200; 250; 300 ; 350; 400 ms MRI SureScn prmeters MRI SureScn MRI Pcing Mode MRI Pcing Rte Additionl pcing fetures PMT Intervention On ; Off PVC Response On ; Off V. Sfety Pcing On ; Off DOO; AOO; VOO; ODO 60; 70; 75; pm Delivered s LV pcing when the AdptivCRT operting vlue is LV. Delivered s RV pcing when RV only pcing is permnently progrmmed. Otherwise, delivered s BiV pcing. Medtronic CreAlert s* Clinicl Mngement Alerts AT/AF Burden nd Rte Settings AT/AF Alerts AT/AF Dily Burden Enle Off ; On Dily AT/AF Burden 0.5; 1; 2; 6 ; 12; 24 hr/24hr Avg. V. Rte During AT/AF Off ; On Enle Dily Burden for 0.5; 1; 2; 6 ; 12; 24 hr/24hr Avg. V. Rte Avg. V. Rte During AT/AF 90; pm Monitored VT Episode Off ; On Detected Led/Device Integrity Alerts Low Bttery Voltge RRT On ; Off Led Impednce Out of Rnge Led Impednce A. Pcing Enle On ; Off A. Pcing Less thn 200 ; 300; 400; 500 Ω A. Pcing Greter thn 1,000; 1,500; 2,000; 3,000 Ω RV Pcing Enle On ; Off RV Pcing Less thn 200 ; 300; 400; 500 Ω RV Pcing Greter thn 1,000; 1,500; 2,000; 3,000 Ω LV Pcing Enle On ; Off LV Pcing Less thn 200 ; 300; 400; 500 Ω LV Pcing Greter thn 800; 1,000; 1,500; 2,000; 3,000 Ω Cpture Mngement High Threshold High Threshold A. Cpture Enle Off ; On RV Cpture Enle Off ; On LV Cpture Enle c Off ; On If progrmmed to On, lert notifiction is sent if A. cpture mngement hs mesured high thresholds for 3 consecutive dys. If progrmmed to On, lert notifiction is sent if RV cpture mngement hs mesured high thresholds for 3 consecutive dys. c If progrmmed to On, lert notifiction is sent if LV cpture mngement hs mesured high threshold for one dy. Totl VP < 90% Off ; On OptiVol 2.0 Fluid Settings Off Oservtion Conditions OptiVol Threshold 30; 40; 50; ; * Connectivity with the Medtronic CreLink network is pending FDA sumission nd pprovl. Alert triggered if percent of cumultive ventriculr pcing is less thn 90% for 7 consecutive dys. Decresing the OptiVol Threshold mkes the device more sensitive to chnges in the ptient s thorcic fluid sttus. Incresing the OptiVol Threshold could dely or prevent device oservtion of significnt chnges in the ptient s thorcic fluid sttus.

6 Longevity Projected service life in yers, with AdptivCRT progrmmed to Adptive BiV nd LV Percent Pcing 500 Ω pcing impednce 600 Ω pcing impednce Atril % RV% LV% 2.5 V 3.5 V 2.5 V 3.5 V 0% 50% 100% % 50% 100% % 50% 100% % 50% 100% Projected service life estimtes re sed on ccelerted ttery dischrge dt nd device modeling s specified. Do not interpret these vlues s precise numers. Brief Sttement Percept /Percept Qud, Seren /Seren Qud, nd Solr / Solr Qud CRT-P MRI SureScn System (Percept/Seren/Solr CRT-P MRI SureScn Systems) Implntle Crdic Pcemkers with Crdic Resynchroniztion Therpy Indictions The Percept/Seren/Solr CRT-P MRI SureScn Systems re indicted for NYHA Functionl Clss III nd IV ptients who remin symptomtic despite stle, optiml hert filure medicl therpy nd hve LVEF 35% nd prolonged QRS durtion nd for NYHA Functionl Clss I, II, or III ptients who hve LVEF 50%, re on stle, optiml hert filure medicl therpy if indicted nd hve trioventriculr lock (AV lock) tht re expected to require high percentge of ventriculr pcing tht cnnot e mnged with lgorithms to minimize right ventriculr pcing. Optimiztion of hert filure medicl therpy tht is limited due to AV lock or the urgent need for pcing should e done post implnt. Rte dptive pcing is provided for those ptients developing rdycrdi indiction who might enefit from incresed pcing rtes concurrent with increses in ctivity. Dul chmer nd tril trcking modes re indicted for ptients who my enefit from mintennce of AV synchrony. Antitchycrdi pcing (ATP) is indicted for termintion of tril tchyrrhythmis in ptients with one or more of the ove pcing indictions. A complete SureScn pcing system is required for use in the MR environment. A complete SureScn pcing system includes SureScn device with Medtronic SureScn leds or Model 6725 pin plug for the right tril port. To verify tht components re prt of SureScn system, visit Contrindictions The Percept/Seren/Solr CRT-P MRI SureScn Systems re contrindicted for concomitnt implnt with nother rdycrdi device nd concomitnt implnt with n implntle crdioverter defirilltor. There re no known contrindictions for the use of pcing s therpeutic modlity to control hert rte. The ptient s ge nd medicl condition, however, my dictte the prticulr pcing system, mode of opertion, nd implnt procedure used y the physicin. Rte-responsive modes my e contrindicted in those ptients who cnnot tolerte pcing rtes ove the progrmmed Lower Rte. Dul chmer sequentil pcing is contrindicted in ptients with chronic or persistent suprventriculr tchycrdis, including tril firilltion or flutter. Asynchronous pcing is contrindicted in the presence (or likelihood) of competition etween pced nd intrinsic rhythms. Single chmer tril pcing is contrindicted in ptients with n AV conduction disturnce. Antitchycrdi pcing (ATP) therpy is contrindicted in ptients with n ccessory ntegrde pthwy. Wrnings nd Precutions A complete SureScn pcing system is required for use in the MR environment. Before performing n MRI scn, refer to the MRI technicl mnul for MRI-specific wrnings nd precutions. A complete SureScn pcing system includes SureScn device with Medtronic SureScn leds or Model 6725 pin plug for the right tril port. Any other comintion my result in hzrd to the ptient during n MRI scn. Chnges in ptient s disese nd/or medictions my lter the efficcy of the device s progrmmed prmeters. Ptients should void sources of mgnetic nd electromgnetic rdition to void possile underdetection, inpproprite sensing nd/or therpy delivery, tissue dmge, induction of n rrhythmi, device electricl reset or device dmge. Do not plce trnsthorcic defirilltion pddles directly over the device. Certin progrmming nd device opertions my not provide crdic resynchroniztion. Elective Replcement Indictor (ERI) results in the device switching to VVI pcing t 65 ppm. In this mode, ptients my experience loss of crdic resynchroniztion therpy nd/or loss of AV synchrony. For this reson, the device should e replced prior to ERI eing set. Use of the device should not chnge the ppliction of estlished nticogultion protocols. Ptients nd their implnted systems must e screened to meet the following requirements for MRI: no implnted led extenders, led dptors, or ndoned leds; no roken leds or leds with intermittent electricl contct s confirmed y led impednce history; SureScn pcing system implnted in the left or right pectorl region. Additionlly, for ptients whose device will e progrmmed to n synchronous pcing mode when MRI SureScn is progrmmed to On, no diphrgmtic stimultion is present t pcing output of 5.0 V nd t pulse width of 1.0 ms. Potentil Adverse Events or Potentil Complictions Potentil complictions include, ut re not limited to, rejection phenomen, erosion through the skin, muscle or nerve stimultion, oversensing, filure to detect nd/or terminte rrhythmi episodes, nd surgicl complictions such s hemtom, infection, inflmmtion, nd thromosis. Other potentil complictions relted to the led my include led dislodgement, led conductor frcture, insultion filure, threshold elevtion, or exit lock. Potentil MRI complictions for the SureScn system include, ut re not limited to, led electrode heting nd tissue dmge resulting in loss of sensing or cpture or oth, or induced currents on leds resulting in continuous cpture, VT/VF, nd/or hemodynmic collpse; spontneous tchyrrhythmi occurring during the scn tht is not detected nd treted ecuse tchyrrhythmi detection is suspended while MRI SureScn is progrmmed to On; potentil for VT/VF induction when the ptient is progrmmed to n synchronous pcing mode during MRI SureScn; device heting resulting in tissue dmge in the implnt pocket or ptient discomfort or oth; or dmge to the functionlity or mechnicl integrity of the device resulting in the inility of the device to communicte with the progrmmer. See the pproprite Percept/Seren/Solr product Device Mnuls for detiled informtion regrding the implnt procedure, indictions, contrindictions, wrnings, precutions, nd potentil complictions/dverse events. See the pproprite Percept/Seren/Solr product MRI SureScn Technicl Mnul efore performing n MRI Scn. For further informtion, cll Medtronic t nd/or consult Medtronic s wesite t www. medtronic.com or Cution: Federl lw (USA) restricts these devices to sle y or on the order of physicin Medtronic 710 Medtronic Prkwy Minnepolis, MN USA Medtronic nd the Medtronic logo re trdemrks of Medtronic. Third prty rnds re trdemrks of their respective owners. All other rnds re trdemrks of Medtronic compny. Toll-free in USA: Worldwide: medtronic.com UC EN 2017 Medtronic. Minnepolis, MN. All Rights Reserved. Printed in USA. 05/2017