It was reported that during an unrelated lead drg revision [manufacturer report number: 1627487-2023-05162, 1627487-2023-05163, 1627487-2023-05164] on (b)(6) 2023, a dural puncture and blood patch were performed.The patient was hospitalized.It is unknown which lead is liable.
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The allegation is against 1 of 3 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: 50cm implant lead kit, slim tip, model: mn10450-50a, udi: (b)(4) , serial: (b)(6) , batch: 9168220.Common device name: 50cm implant lead kit, slim tip, model: mn10450-50a, udi: (b)(4) , serial: (b)(6) , batch: 9168223.
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The event of dural puncture and blood patch during revision was reported to abbott.During an unrelated lead drg revision, a dural puncture and blood patch were performed.The patient was hospitalized.It is unknown which lead is liable.No further intervention planned.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
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