Model Number V173 |
Device Problem
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 06/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device has been returned for analysis.This report will be updated upon completion of analysis.
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) device reverted to safety mode with limited critical therapy still available.Subsequently, the unipolar pacing mode of the left ventricular lead caused diaphragmatic stimulation.As a result, the device was 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.It was confirmed that brady therapy remained available.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) device reverted to safety mode with limited critical therapy still available.Subsequently, the unipolar pacing mode of the left ventricular lead caused diaphragmatic stimulation.As a result, the device was explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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