Model Number 3664 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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¿date of event¿ is estimated.During processing of this complaint, attempts were made to obtain complete event information.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 elective replacement indicator (eri) message appeared for ipg.The eri message was determined to be true.It is unknown if the ipg depleted prematurely.The device was providing therapy.As a result, surgery 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 was received that surgery occurred during which the ipg was explanted and replaced to address the issue.
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Search Alerts/Recalls
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