Model Number V173 |
Device Problems
Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/11/2021 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode during routine check.It was reported that on the external telemetry monitor a fifteen second pause was observed.It was recommended that this device be replaced and the patient have external pacing support until device replacement.The device was subsequently explanted and 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.The system resets occurred during a telemetry session 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 this cardiac resynchronization therapy pacemaker (crt-p) was found to be in safety mode during routine check.It was reported that on the external telemetry monitor a fifteen second pause was observed.It was recommended that this device be replaced and the patient have external pacing support until device replacement.The device was subsequently explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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