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Model Number MN10450-50A |
Device Problem
Migration (4003)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 04/02/2024 |
Event Type
Injury
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Event Description
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It was reported that one of the patient's drg leads had migrated.The migration was confirmed via x-ray imaging.Surgical intervention was undertaken on (b)(6) 2024 wherein the patient's migrated lead was explanted, replaced, and therapy was restored.
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Manufacturer Narrative
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Section b3: event date is estimated.The allegation is against one of two leads; however, it is unknown which leads, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 6958790.
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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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