Model Number 3660 |
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 Date 12/23/2020 |
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 the patient¿s controller displayed the elective replacement indicator (eri) message.As a result, the patient may undergo surgical intervention 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.There were no complications during the procedure.
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Search Alerts/Recalls
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