Model Number V173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Presyncope (4410)
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Event Date 02/25/2021 |
Event Type
Injury
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Event Description
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It was reported that the cardiac resynchronization therapy pacemaker (crt-p) displayed an alert indicating it had entered safety mode.The patient had symptoms of presyncope.The device was explanted and a new crt-p was successfully implanted.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 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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Event Description
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It was reported that the cardiac resynchronization therapy pacemaker (crt-p) displayed an alert indicating it had entered safety mode.The patient had symptoms of presyncope.The device was explanted and a new crt-p was successfully implanted.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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