Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Pain (1994); Post Operative Wound Infection (2446)
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Event Date 06/03/2020 |
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 the patient experienced pain and swelling due to an infection at the ipg site.As a result, surgical intervention was undertaken on (b)(6) 2020 wherein the entire system was explanted.The patient was hospitalized and received both oral and iv antibiotics.
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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 indicates the infection has since been resolved.
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Search Alerts/Recalls
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