BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 4919505 · Received July 10, 2015

    Report

    Report Number
    9681449-2015-00001
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    June 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    PMA / PMN Number
    K033130
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(4): DISTRIBUTION PARTNER MEDTRONIC INFORMED US ON (B)(6) 2015 ABOUT THE FOLLOWING EVENT: IT WAS REPORTED THE PATIENT WENT INTO ASYSTOLE WHEN THE PACING CABLES ON THE EXTERNAL PULSE GENERATOR (EPG) "POPPED OUT" AFTER THEY WERE SECURED INTO THE DEVICE. IT WAS DETERMINED THAT PRONGS WERE NOT COMPLETELY TIGHTENED AND THE CABLES SLID OUT. TROUBLESHOOTING SHOWED THE PRONGS CAME LOOSE. FOLLOW UP REVEALED THE TEMPORARY LEAD WAS PLACED IN THE INTENSIVE CARE/CARDIAC CARE UNIT WHEN THE PATIENT WENT INTO SHOCK. THE PATIENT WAS TRANSFERRED TO THE CATHARIZATION LAB FOR PERMANENT PLACEMENT AND WHEN THE PATIENT WAS MOVED THE LEAD "POPPED OUT." THE PATIENT WENT INTO ASYSTOLE AND THERE WAS ELECTRO-MECHANICAL DISSOCIATION. THE LEAD WAS THEN TIGHTENED DOWN, CARDIO-PULMONARY RESUSCITATION WAS STARTED AND THE PATIENT EXPIRED 45 MINUTES TO ONE HOUR LATER. THE STATUS OF THE EPG IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448764 MEDTRONIC EXTERNAL PACEMAKER DTE OSYPKA MEDICAL GMBH 5391

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death