Model Number PM2272 |
Device Problems
Premature Discharge of Battery (1057); Difficult to Interrogate (1331); Interrogation Problem (4017)
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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 09/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that the patient presented in clinic for routine device check.Interrogation was noted to be prolonged.It was found that the patient's pacemaker had been in end of service (eos) status unexpectedly.Premature depletion was alleged on the device.The device was explanted and replaced.The patient was stable.
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Manufacturer Narrative
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The field complaint of premature battery depletion was confirmed.Final analysis found a battery anomaly in which elevated current drain from the hybrid circuitry resulted in end-of-life status earlier than the projected longevity of the device.
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Manufacturer Narrative
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The reported event of premature battery depletion was confirmed and interrogation problem was not confirmed.Final analysis found unknown high leakage current for nine months.Device image was retrieved and analyzed, indicating elevated current within a period of the implant duration due to the duty cycle of the internal circuitry caused by a firmware anomaly.Additional testing indicated normal device functionality and high current condition could non-reproducible.
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Search Alerts/Recalls
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