Model Number 3662 |
Device Problem
Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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It was reported that the patient's ipg had reached reaching end of life.Surgical intervention may occur to address the issue.
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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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Additional information received indicates that the patient underwent surgical intervention during which the ipg was explanted and replaced.
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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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Manufacturer Narrative
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Upon review, the issue should not have been submitted as a medical device report (mdr) as device analysis confirmed normal battery depletion.
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Search Alerts/Recalls
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