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 09/14/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) was hospitalized due to non-device related reasons.Device interrogation was performed and it was found the device had exhibited error codes and reverted to safety mode.The device was successfully explanted and replaced.No additional adverse patient effects were reported.The product has been received 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 the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) was hospitalized due to non-device related reasons.Device interrogation was performed and it was found the device had exhibited error codes and reverted to safety mode.The device was successfully explanted and replaced.No additional adverse patient effects were reported.The product has been received for analysis.This report will be updated upon completion of analysis.
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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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Search Alerts/Recalls
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