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:

Download: Boston Scientific ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, and VALITUDE Pacemakers Field Safety Notice

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