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 during implant attempt, the left ventricular (lv) lead was placed into the left ventricular lateral vein.Testing measured high impedance on all configurations.A new target vessel was obtained, but still exhibited poor impedance and there was no pacing at high output.Moving the lead forward or backward to several positions did not resolve the issue.Lead fracture was suspected.The lead was removed.The physician implanted a dual chamber implantable cardioverter defibrillator (icd) system instead.No patient complications have been reported as a result of this event.
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