Model Number U128 |
Device Problem
Data Problem (3196)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.
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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 while implanted in the patient.Surgical intervention was performed and the crt-p was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The returned device was thoroughly inspected and analyzed.Visual inspection noted tool marks on the case and header, but identified no further anomalies.A review of the device memory noted two fault codes.The general diagnostics portion of the memory dump confirmed the double bit fault.After performing a telemetry reset the device went to primary operation and the device was observed to pass automated electrical testing.The allegation made against the device was confirmed through product testing.The device went into safety core due to the double bit faults.The cause of the memory corruption was unable to be determined.
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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 while implanted in the patient.Surgical intervention was performed and the crt-p was explanted and replaced.No additional adverse patient effects were reported.This product has just been returned back from the field for analysis.This report will be updated upon completion of analysis.
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Search Alerts/Recalls
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