Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Post Operative Wound Infection (2446)
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Event Date 08/19/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event is estimated.During processing of this incident, attempts were made to obtain complete event and patient information.Further information was requested but not received.
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Event Description
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Related manufacturer reference number: 1627487-2022-04951; related manufacturer reference number: 1627487-2022-04953.It was reported that there were infection concerns as the patient¿s wound was not healing properly.As such, surgical intervention took place on (b)(6) 2022 wherein the entire system was explanted to address the issue.
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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 indicates that the suspected infection was at the ipg pocket.Reportedly, there ended up being no infection but a fistula from the skin.This issue had been resolved.
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Search Alerts/Recalls
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