Model Number DM3500 |
Device Problems
Premature Discharge of Battery (1057); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported one-day post-implant, low battery voltage was observed.The device remains implanted.There were no adverse health consequences to the patient.
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Manufacturer Narrative
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Correction: please retract this report 2017865-2021-08833, as the event did not indicate a malfunction caused a serious event.
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Event Description
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New information received indicated that the device had a normal expected behavior and no anomaly.
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Search Alerts/Recalls
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