BOSTON SCIENTIFIC CORPORATION MOMENTUM CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
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Model Number G125 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Bradycardia (1751); Cardiac Arrest (1762)
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Event Date 08/09/2023 |
Event Type
Injury
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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 during a device changeout procedure after pulling out the right ventricular (rv) lead from the previous device and connected to this cardiac resynchronization therapy defibrillator (crt-d) no pacing was performed.The pacing inhibition resulted in this pacemaker dependent patient going into cardiac arrest for approximately 13 seconds.It was noted that backup pacing occurred with an analyzer.It was found that this crt-d had been in storage mode.Once the field representative arrived, storage mode had cleared, and the rv lead was connected once again to this crt-d and no further problem were observed.Technical services (ts) discussed stat pacing and storage mode programming with the field representative.This crt-d remains in service.No adverse patient effects were reported.
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Search Alerts/Recalls
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