ST. JUDE MEDICAL - NEUROMODULATION KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG SLIM TIP LEAD
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Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Pain (1994); Swelling (2091)
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Event Date 08/04/2020 |
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 patient information.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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Related manufacturer reference numbers: 1627487-2020-30638, 1627487-2020-30640, 1627487-2020-30641.It was reported that during the patient experienced pain at the ipg site on (b)(6) 2020 following an ipg pocket revision (related manufacturer reference number 1627487-2020-23789) on (b)(6) 2020.It was discovered that the ipg and lead sites were swollen to the touch.In turn, the patient underwent surgical intervention on (b)(6) 2020 wherein the entire drg system was explanted.No signs of infection were present, however there was a large hematoma at both the ipg and lead sites.Post-operatively, the patient is recovering.
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