BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3123516 · Received May 9, 2013

    Report

    Report Number
    3123516
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 22, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC
    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

    NOTES FROM THE DISCHARGE SUMMARY: "RECENTLY, THE PATIENT HAS HAD SYMPTOMS OF FATIGUE AND PACEMAKER SYNDROME ASSOCIATED WITH DYSFUNCTION OF HIS ATRIAL PACER LEAD. THE PATIENT HAS HAD MULTIPLE INFECTIONS IN THE PAST AND ALTHOUGH THE DEVICE HAD NOT REACHED ELECTIVE REPLACEMENT INDICATOR (ERI), IT DID HAVE SIGNIFICANT BATTERY DEPLETION. ACCORDINGLY, THE PATIENT WAS ADMITTED FOR ATRIAL LEAD REPLACEMENT AND GENERATOR REPLACEMENT...HOSPITAL COURSE:...THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE HIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) GENERATOR WAS REPLACED AND AN UNCOMPLICATED ATRIAL LEAD EXTRACTION/REINSERTION WAS CARRIED OUT. POSTOPERATIVELY, HE HAD ADEQUATE PAIN MANAGEMENT AND HIS WOUND WAS HEALING WITHOUT INCIDENT." PLEASE NOTE, THE ICD WAS IMPLANTED IN MEXICO AND WE DO NOT HAVE SPECIFIC DATA FOR THE IMPLANT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXPLANT ICD GENERATOR.IMPLANT ICD GENERATOR, MEDTRONIC MODEL D314TRG.RIGHT ATRIAL LEAD EXTRACTION.RIGHT ATRIAL LEAD INSERTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204649 * PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR