Continuation of d10: ddmb1d4 icd; implant date (b)(6) 2024.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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It was reported that a week after an implantable cardioverter defibrillator (icd) changeout procedure, the right ventricular (rv) lead triggered alerts for high/undefined pacing impedance.It was also noted that the superior vena cava (svc) and rv coil impedances jumped and measured high/undefined, but no alerts were triggered on the icd.It was reported that there was ¿lots of stabbing¿ during the icd changeout and a lead fracture was suspected.The icd and lead remain in use.No patient complications have been reported as a result of this event.
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