Model Number V173 |
Device Problems
Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Dizziness (2194)
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Event Date 08/31/2022 |
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) had presented to the emergency room with lightheadedness and dizziness.The crt-p was found to be in safety core, and myopotential oversensing and pacing inhibition were noted.Technical services (ts) was consulted and recommended device replacement.The crt-p was explanted due to premature battery depletion (pbd) and successfully replaced.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.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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Event Description
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It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) had presented to the emergency room with lightheadedness and dizziness.The crt-p was found to be in safety core, and myopotential oversensing and pacing inhibition were noted.Technical services (ts) was consulted and recommended device replacement.The crt-p was explanted due to premature battery depletion (pbd) and successfully replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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