BOSTON SCIENTIFIC CORPORATION RESONATE X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G447 |
Device Problems
Over-Sensing (1438); Pacing Problem (1439); Data Problem (3196)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2024 |
Event Type
malfunction
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that electrogram (egm) review of this cardiac resynchronization therapy defibrillator (crt-d) system revealed inappropriate mode switching due to farfield signal oversensing.Additionally, some episodes showed right ventricular (rv) and left ventricular (lv) pacing.Technical services (ts) explained that in atrial tachy response (atr) fallback, there was always biventricular pacing regardless of pacing chamber settings.Technical services (ts) reviewed troubleshooting options and programming considerations.This crt-d remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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