It was reported that during the implant procedure, after trying three different locations of the same lateral branch and connecting the left ventricular (lv) lead to the device the lead impedance went up higher than initially showed on the analyzer and was out of range.The physician checked the header and ensured proper connections.The lead was then disconnected, tested again and reconnected to the device.The impedance had gone down slightly and the lead was implanted and remains in use however there was still concern of high thresholds and impedance. no patient complications have been reported as a result of this event.
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Continuation of d10: w4tr01 crt-p implanted: (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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