Hydrogen-Induced Accelerated Battery Depletion Advisory
Boston Scientific is expanding a previously communicated advisory related to hydrogen-induced accelerated battery depletion in certain pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps). This advisory affects a population of pacemakers built with specific, discontinued low voltage capacitors.
The clinical impact of this behavior is early device replacement, with a low risk of life-threatening harm. Recommendations for physicians and healthcare professionals include:
- Following up with patients every 12 months to assess battery performance.
- Replacing affected pacemakers suspected of exhibiting accelerated battery depletion within 90 days of the Explant battery status indicator.
- Maintaining accurate medical records for patients with affected pacemakers.
Full product performance information, including a device lookup tool, is available at www.bostonscientific.com/ppr.
Manual:
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