Model Number V173 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/18/2022 |
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.The device was subsequently explanted and replaced.No additional adverse patient effects were reported outside of this procedure.This product is expected to be returned.
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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.
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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.The device was subsequently explanted and replaced.No additional adverse patient effects were reported outside of this procedure.This product is expected to be returned.
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Search Alerts/Recalls
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