ABBOTT MEDICAL 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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Model Number 6372 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Skin Erosion (2075)
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Event Date 08/18/2023 |
Event Type
Injury
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Manufacturer Narrative
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B3: event date is estimated.The allegation is against 1 of 2 components; however, it is unknown which component(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: dbs lead extension, model: 6372, udi: (b)(4), serial: (b)(6), batch: 8684538.
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Event Description
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It was reported that the patient had open skin over their extension.The investigation did not determine which extension contributed to this issue.Surgical intervention was undertaken, and the extension was explanted.
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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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