Model Number 3662 |
Device Problem
Insufficient Information (3190)
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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 Type
Injury
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Manufacturer Narrative
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Date of event is unknown.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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Manufacturer reference number: 1627487-2020-49379.It was reported that the patient's system was explanted (b)(6) 2020 for an unspecified reason.
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Manufacturer Narrative
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Analysis of the returned ipg found it had no physical anomalies, communicated with all lab utilities, and passed all functional testing on the ate.Discomfort or pain at the ipg site is commonly associated with patient anatomy and/or the location of the ipg pocket site.
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Search Alerts/Recalls
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