ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS TRIAL LEAD
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Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 09/08/2022 |
Event Type
Injury
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Event Description
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Related manufacturer reference number: 3006705815-2022-16965.It was reported that the patient underwent a scs trial and the leads were removed on (b)(6) 2022.Reportedly, the patient experienced a mssr infection one week and a day after the leads were removed.As such, surgical intervention was undertaken and patient was treated at the hospital.Patient has been discharged.
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Manufacturer Narrative
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Date of event is estimated.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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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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