Field Safety Notices
Boston Scientific has issued two separate Field Safety Notices related to pacing system behaviors in INGENIOTM Family DR EL Pacemakers and CRT-Ps.
Notice 1: High Battery Impedance May Initiate Safety Mode
This notice affects dual chamber INGENIOTM family pacemakers and CRT-Ps, which may initiate Safety Mode due to increased battery impedance prior to replacement indicators. This can cause system resets and early device replacement.
Notice 2: Hydrogen Induced Accelerated Battery Depletion
This notice affects a subset of pacemakers from the ACCOLADETM family, which may experience elevated likelihood for early replacement due to accelerated battery depletion.
Boston Scientific has discontinued manufacturing dual chamber INGENIO EL pacemakers and CRT-Ps, and no affected devices remain available for implant.
Physicians and healthcare professionals are advised to schedule replacement of affected devices and to report any clinical events to Boston Scientific.
Manual:
Download: INGENIOTM Family DR EL Pacemakers and CRT-Ps User Manual
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