Model Number V173 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Bradycardia (1751)
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Event Date 10/28/2021 |
Event Type
Injury
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Event Description
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It was reported that this pacemaker was found to be in safety mode.Subsequently, the device was explanted and replaced with a new device.It was noted that there was some pacing inhibition during the changeout procedure.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If additional information is received, a supplemental report will be filed at that time.
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Event Description
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It was reported that this pacemaker was found to be in safety mode.Subsequently, the device was explanted and replaced with a new device.It was noted that there was some pacing inhibition during the changeout procedure.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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