The allegation is against 1 of 2 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: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9202264.
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It was reported to abbott, a patient underwent a lead revision due to having a suspected lead fracture following a fall.During the procedure the suspected lead was replaced.Additionally, the patient experienced a csf leak.A ct scan was undertaken with no noted abnormalities and a blood patch was performed to address the issue.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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