ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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Model Number 3186 |
Device Problem
Migration (4003)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/05/2021 |
Event Type
Injury
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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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Related manufacturer report number: 3006705815-2021-04122, 3006705815-2021-04314.It was reported the patient's lead had migrated.As a result, the patient underwent surgical intervention on (b)(6) 2021 during which the lead was repositioned.The patient has functioning therapy.It is unknown which lead had migrated, so all potential leads are being reported.
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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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Search Alerts/Recalls
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