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 there was a connection issue with the right ventricular (rv) lead and the cardiac resynchronization therapy defibrillator (crt-d) that presented as impedance issues and oversensing.The crt-d and rv lead remain in use.Additional information received noted a pocket revision was done.It was noted that during the implant procedure, the right ventricular (rv) lead parameters measurements were ok.It was also noted that post implant procedure, there was no pacing in any configuration on the rv lead and impedance measurements were high.A pockets revision was performed on the following day and connections were verify.There was again no pacing and impedance were out of range high.Another pocket revision was performed.No patient complications have been reported as a result of this event.
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