BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 3932771 · Received July 9, 2014

    Report

    Report Number
    MW5037234
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    DTE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PATIENT OF EXTERNAL EPICARDIAL PACER WAS BEING VENTRICULAR PACED, ASYSTOLE IS UNDERLYING RHYTHM. TEMPORARY PACEMAKER SHUT DOWN SPONTANEOUSLY (PACING LIGHTS WERE ON A AND V REMAINED SOLID GREEN WITH BLANK SCREEN) (HAD BATTERY FROM (B)(6) 2014) NO LOW BATTERY SIGNAL. PACEMAKER ABLE TO BE TURNED BACK ON ONCE REMOVED FROM PATIENT. NEW PACEMAKER IN ROOM ATTACHED TO PATIENT AND FUNCTIONED. PATIENT MOMENTARILY LOST CONSCIOUSNESS WITH ASYSTOLE. PATIENT WENT TO CATH LAB FOR PERMANENT PACER IMMEDIATELY FOLLOWING INCIDENT. MEDTRONIC REP NOTIFIED AND TOOK PACER TO MEDTRONIC FOR VERIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399066 MEDTRONIC EXTERNAL TEMPORARY PACEMAKER DTE MEDTRONIC 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R