Impact of Cycling Feature on Longevity and Recharge Interval Activa PC, Activa RC, and Activa SC

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1 Impact of Cycling Feature on Longevity and Recharge Interval Activa PC, Activa RC, and Activa SC Current labeling indicates the use of cycling improves battery longevity and recharge interval under all programming scenarios; however, enabling cycling at certain parameter settings may decrease the recharge interval for rechargeable devices and the device longevity of non-rechargeable devices. Neurostimulators impacted by this issue when cycling is enabled at some parameter settings: Brain Modulation Neurostimulators (Model) Activa RC (37612) Activa SC (37602 and 37603) Activa PC (37601) Activa PC+S (37604) (investigational use) The following information represents an overview of changes that will be made to labeling. Impacted Product Name (Model Number) 1 Activa PC (37601) Activa SC (37602 and 37603) Summary of Corrections to Labeling The use of cycling may cause a reduction in battery longevity. When calculated adjusted energy use values are at or above 184, cycling at intervals less than 15 seconds on and less than 15 seconds off may reduce battery longevity. Cycling is not recommended for improving battery longevity for devices with calculated adjusted energy use values below 184. Activa RC (37612) <End Summary> The corrected method for estimating battery longevity can be found in the section below titled Method of calculation for estimating battery longevity for Activa PC and Activa SC Neurostimulators. The use of cycling may cause a reduction in time between recharge sessions. An additional reminder will be added: Battery charge levels should be monitored using either the recharger or patient programmer. 1 Activa PC+S Model is impacted but is for investigational use only February 2014 online at professional.medtronic.com/cycling Page 1 of 9

2 Method of calculation for estimating battery longevity for Activa PC and Activa SC Neurostimulators. The following formula estimates the approximate period of time that a new Activa PC and Activa SC Neurostimulator battery will last. The estimation is based on the settings for one group. Programs 3 and 4 are available in Activa PC only. Steps for estimating battery longevity 1. The estimation formula is based on expected programmed values, the modes of operation, the measured impedance, and how often the therapy is used: Expected programmed values Program 1 Program 2 Program 3 a Program 4 a Amplitude: V/mA Amplitude: V/mA Amplitude: V/mA Amplitude: V/mA Rate b : Hz Rate b : Hz Rate b : Hz Rate b : Hz Pulse width: μsec Pulse width: μsec Pulse width: μsec Pulse width: μsec Impedance: ohms Impedance: ohms Impedance: ohms Impedance: ohms Modes of operation and use Hours of Stimulation/day: Hours/day a Programs 3 and 4 are available in Activa PC only. b Rates for Programs 1, 2, 3, and 4 are the same. Program 1 (P1) 2. Using the amplitude, rate, and pulse width, locate the energy use (EU) for Program 1 from Table 1 (if voltage mode is applied) or from Table 3 (if current mode is applied): 3. Locate the Impedance Correction Factor (ICF) for Program 1 based on the measured impedance from Table 2 (voltage mode) or Table 4 (current mode): 4. Compute the Program 1 Factor (P1F): P1EU P1ICF = P1F Program 2 (P2) 5. For a second program, repeat steps 1 3 to compute the Program 2 Factor (P2F): P2EU P2ICF = P2F Program 3 (P3) Activa PC only 6. For a third program, repeat steps 1 3 to obtain the Program 3 Factor (P3F): February 2014 online at professional.medtronic.com/cycling Page 2 of 9

3 P3EU P3ICF = P3F Program 4 (P4) Activa PC only 7. For a fourth program, repeat steps 1 3 to obtain the Program 4 Factor (P4F): P4EU P4ICF = P4F Computing the multi-program factor (MPF) 8. Compute the MPF (use 0 for unused programs): P1F + P2F + P3F + P4F = MPF 9. Determine the Usage Correction Factor (UCF) using the hours of stimulation per day: Hours of stimulation per day 24 hours = UCF 10. Compute the adjusted Energy Use value: MPF UCF + [24.4 x (1 - UCF )] = Adjusted Energy Use 11. Use the adjusted Energy Use value and determine the battery longevity from Figure 1 and Figure 2. February 2014 online at professional.medtronic.com/cycling Page 3 of 9

4 Figure 1. Activa PC Neurostimulator longevity estimates (years) for energy use and cycling impact. February 2014 online at professional.medtronic.com/cycling Page 4 of 9

5 Figure 2. Activa SC Neurostimulator longevity estimates (years) for energy use and cycling impact. February 2014 online at professional.medtronic.com/cycling Page 5 of 9

6 Table 1. Activa PC and Activa SC Neurostimulator energy use for voltage mode a Pulse width Amplitude (V) Rate NA NA NA NA NA NA NA NA NA NA a Use values that are closest to the expected values (round to the next highest value). February 2014 online at professional.medtronic.com/cycling Page 6 of 9

7 Table 2. Activa PC and Activa SC Neurostimulator final impedance correction factor (ICF) for voltage mode a Impedance ICF b c 0.50 a Use value closest to the measured impedance value (round to the next lowest impedance value). b With a programmed amplitude of 1V, calculated longevity may overestimate actual longevity by 1 to 2 years. c Calculated longevity may overestimate actual longevity by 1 to 2 years. February 2014 online at professional.medtronic.com/cycling Page 7 of 9

8 Table 3. Activa PC and Activa SC Neurostimulator energy use for current mode a Pulse width Amplitude (ma) Rate NA NA NA NA NA NA NA NA NA NA a Use values that are closest to the expected values (round to the next highest value). February 2014 online at professional.medtronic.com/cycling Page 8 of 9

9 Table 4. Activa PC and Activa SC Neurostimulator final impedance correction factor (ICF) for current mode a Impedance ICF 500 b b a Use value closest to the measured impedance value (round to the next highest impedance value). b With a programmed amplitude of 1 ma, calculated longevity may overestimate actual longevity by 1 to 2 years. February 2014 online at professional.medtronic.com/cycling Page 9 of 9

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