BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC PACEMAKER

    MDR report key: 3874060 · Received June 11, 2014

    Report

    Report Number
    MW5036574
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 5, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH TEMPORARY PACEMAKER DUE TO LOW HR IN 30'S. TEMP PACER TURNED OFF WITHOUT WARNING LEAVING THE PT IN ASYSTOLE AND REQUIRING CPR. DEVICE TURNED BACK ON BY NURSE AND PT HR INCREASED BACK TO PRIOR SETTING. AGAIN WITHOUT WARING THE TEMP PACEMAKER TURNED OFF ON ITS OWN. DEVICE WAS EXCHANGED AND TAKEN OUT OF SERVICE. DIAGNOSIS OR REASON FOR USE: HEART RATE IN 30'S (BRADYCARDIA WITH SYMPTOMS). EVENT ABATED AFTER USE STOPPED OR DOES REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344135 MEDTRONIC PACEMAKER DUAL CHAMBER TEMP PACEMAKER DTE MEDTRONIC 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR