Model Number 3662 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/04/2020 |
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 occurred to explant and replace the ipg to address the issue.
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Manufacturer Narrative
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Correction: manufacturer report number 1627487-2020-49014 should not have been submitted as a medical device report (mdr) as the device meets or exceeds 75% of expected longevity.There is no device malfunction.
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Search Alerts/Recalls
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