Model Number V173 |
Device Problems
Over-Sensing (1438); Pacing Problem (1439); Inappropriate or Unexpected Reset (2959)
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Patient Problem
Asystole (4442)
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Event Date 09/25/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced myopotential oversensing and pauses due to the unipolar sensing configuration caused by safety core.It was known that the crt- p was at elective replacement indicator (eri) and exhibited pacing inhibition with greater than two seconds of asystole.Technical services (ts) discussed the safety mode features and parameters with the physician.Subsequently, the crt-p was explanted and replaced with a new device.No additional adverse patient effects were reported.The device has been returned and analysis is pending.This report will be updated with pertinent information upon completion of analysis.
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Event Description
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It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) experienced myopotential oversensing and pauses due to the unipolar sensing configuration caused by safety core.It was known that the crt- p was at elective replacement indicator (eri) and exhibited pacing inhibition with greater than two seconds of asystole.Technical services (ts) discussed the safety mode features and parameters with the physician.Subsequently, the crt-p was explanted and replaced with a new device.No additional adverse patient effects were reported.The device has been returned and analysis is pending.This report will be updated with pertinent information upon completion of analysis.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode due to system resets.The system resets caused the device to enter safety mode.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance resulted in the system resets due to temporary high-power consumption related to telemetry attempts and subsequent reversion to safety mode operation.Boston scientific has issued a field safety notice regarding ingenio extended life (el) and cardiac resynchronization therapy pacemaker (crt-p) devices that may exhibit this behavior.This particular device is included in the high impedance in ingenio extended life (el) pacemaker and crt-p advisory population.
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Search Alerts/Recalls
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