Medtronic received information that one day following the implant of a bioprosthetic valve, first degree atrioventricular block (avb) which progressed to second degree avb.Then an episode of complete heart block with a stable escape rhythm was reported.Temporary pacing was used as needed and physician consulted felt a permanent pacemaker was needed.Three days following a dual chamber permanent pacemaker was implanted.No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
|