| Reason for the Action |
The non-rechargeable IPG battery longevity estimate (provided as the Energy Use Index [EUI]) and rechargeable IPG battery recharge estimate are supplemental informational tools intended to support IPG replacement and recharge planning, respectively. These estimates are not intended to provide real-time ongoing monitoring of battery status.
Boston Scientific is updating the Programming Manual Instructions for Use to provide additional guidance in the use of the Clinician Programmer feature for Implantable Pulse Generator (IPG) battery recharge interval and non-rechargeable IPG battery longevity estimates.
If the actual impedance of the active contacts are higher or lower than 1,000 ohms(?), the battery longevity or recharge estimate will decrease or increase accordingly relative to the actual impedance values. An inaccurate estimate does not interrupt therapy or directly cause patient harm. However, if this results in delayed battery replacement or inadequate recharging, subsequent battery depletion could result in interruption of stimulation. |