Model Number V173 |
Device Problems
Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 03/02/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient with a cardiac resynchronization therapy pacemaker (crt-p) presented to (b)(6) hospital emergency room.Upon examination there were observations of intermittent loss of capture and pacing spikes on the hospital monitor.The patient requested to be transferred to (b)(6) hospital as she just recently moved.An interrogation was performed at (b)(6) and it was found the device was in safety mode and almost at elective replacement indicator (eri).Additionally, it was noted there was myopotential oversensing which resulted in five to six seconds of pacing inhibition.This prompted for an emergent device change out.The patient is therapy dependent.The device was explanted and replaced successfully.The device will be returned to boston scientific for device analysis.No additional adverse patient effects were reported.
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Event Description
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It was reported that the patient with a cardiac resynchronization therapy pacemaker (crt-p) presented to sinova hospital emergency room.Upon examination there were observations of intermittent loss of capture and pacing spikes on the hospital monitor.The patient requested to be transferred to roanoke memorial hospital as she just recently moved.An interrogation was performed at roanoke and it was found the device was in safety mode and almost at elective replacement indicator (eri).Additionally, it was noted there was myopotential oversensing which resulted in five to six seconds of pacing inhibition.This prompted for an emergent device change out.The patient is therapy dependent.The device was explanted and replaced successfully.The device will be returned to boston scientific for device analysis.No additional adverse patient effects were reported.
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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.It was confirmed that brady therapy remained available.The system resets occurred during a telemetry session and 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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