Model Number 3664 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pain (1994)
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Event Date 07/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.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 patient had a suspected infection at the ipg site causing pain.In turn, surgical intervention was undertaken on (b)(6) 2020 wherein the ipg was repositioned.There were no signs of infection.Post-operatively, the pain subsided and stimulation therapy was restored.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Event Description
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Additional information received stated that the ipg was explanted on (b)(6) 2020 due to a hematoma (related manufacturer reference numbers: 1627487-2020-30638, 1627487-2020-30639, 1627487-2020-30640, 1627487-2020-30641).
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Search Alerts/Recalls
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