Model Number 1192 |
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 10/18/2021 |
Event Type
Injury
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Event Description
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Related manufacturer reference numbers: 3006705815-2021-05557, 3006705815-2021-05558, 3006705815-2021-05559, 1627487-2021-18195.It was reported that the patient experienced an infection of their ipg and lead sites.As a result, surgical intervention took place wherein the entire scs system was explanted.The patient was prescribed antibiotics.
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Manufacturer Narrative
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Date of event is estimated.
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Event Description
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Additional information received stated that the patient's infection had resolved.
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Manufacturer Narrative
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A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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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Search Alerts/Recalls
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