BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN CAPSUREFIX

    MDR report key: 3130414 · Received May 13, 2013

    Report

    Report Number
    3130414
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Date of Event
    March 30, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT UNDERWENT MEDTRONIC DUAL-CHAMBER DEVICE INSERTION FOR TRIFASCICULAR BLOCK. THE PATIENT WAS ADMITTED SIX MONTHS LATER FOR EVALUATION OF ALTERATION IN MENTAL STATUS. ONE DAY LATER THE DEVICE WAS INTERROGATED AND THE RESULTS REVIEWED. THE DEVICE SHOWS NORMAL FUNCTION, AND IS GENERALLY PACING UP TO 60% TO 70% OF THE TIME. NO ARRHYTHMIAS DETECTED.THE NEXT DAY, THE PATIENT HAD A FRANK SYNCOPAL EPISODE. THREE DAYS LATER, THE CARDIOLOGIST NOTED: "THE PATIENT HAD MULTIPLE EPISODES OF NON-CAPTURE AND PAUSES FOR SEVERAL SECONDS OVERNIGHT. THIS WAS DURING SLEEP AND HE WAS ASYMPTOMATIC. THE DEVICE INTERROGATION REVEALS MARKEDLY ELEVATED VENTRICULAR LEAD THRESHOLD AND THE OUTPUT WAS INCREASED TO MAXIMUM OF 6 V AT 1.5 MSEC. HE SAYS HE FEELS TIRED AND WEAK, AND DID NOT SLEEP WELL LAST NIGHT. HE HAS HAD A COUPLE OF EPISODES OF DIZZINESS." THE PATIENT UNDERWENT PACER LEAD EXTRACTION AND PACER LEAD INSERTION AND FLUOROSCOPY. NOTES FROM THE OPERATIVE REPORT: "EXAMINATION OF THE PATIENT'S LEAD UNDER FLUOROSCOPY WAS UNREVEALING. THE LEAD APPEARED TO BE IN GOOD POSITION WITHIN THE FLOOR OF THE RIGHT VENTRICLE AND HAD ACTIVE MOTION WITH HEART BEAT. THERE WERE NO OBVIOUS LEAD FRACTURES VISIBLE BY FLUOROSCOPIC EXAMINATION."..."A STYLET WAS PASSED DOWN THE OLD RIGHT VENTRICULAR ELECTRODE AND THE ACTIVE FIXATION DEVICE WITHDRAWN. UNDER FLUOROSCOPIC GUIDANCE WITH CONSTANT GENTLE TRACTION AND SOME ROTATIONAL TORSION, THE OLD LEAD WAS REMOVED. EXAMINATION OF THE LEAD OVER ITS ENTIRE EXTENT VISUALLY SHOWED NO EVIDENCE OF ABNORMALITIES."... "TOLERATED THE PROCEDURE WELL."WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PACER LEAD EXTRACTION; PACER LEAD INSERTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212139 SURESCAN CAPSUREFIX PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC 5086MRI-52CM *

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR