BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER

    MDR report key: 7036844 · Received November 16, 2017

    Report

    Report Number
    1035166-2017-00099
    Event Type
    Death
    Date Received
    November 16, 2017
    Date of Event
    June 9, 2015
    Report Date
    November 16, 2017
    Manufacturer
    OSYPKA MEDICAL GMBH
    Product Code
    DTE
    UDI-DI
    00643169382978
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    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 THE 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. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED FROM THE PHYSICIAN THAT THE PRIMARY CAUSE OF DEATH IS BELIEVED TO BE LACTIC ACIDOSIS AND SECONDARY BRADYCARDIA. FOLLOW-UP REQUESTS FOR FURTHER INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818313 MEDTRONIC SINGLE CHAMBER EXTERNAL PACEMAKER PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE OSYPKA MEDICAL GMBH 5391 00643169382978

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death