BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTRUST AT

    MDR report key: 2883949 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12174
    Event Type
    Death
    Date Received
    December 21, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016/S046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER BEING SHOCKED EXTERNALLY IN THE AMBULANCE IN ROUTE TO THE HOSPITAL. THE PATIENT RECEIVED CPR AND WAS PRONOUNCED DEAD. IT WAS ALSO NOTED THAT THE PATIENT WAS RECEIVING SHOCKS AFTER BEING PRONOUNCED DEAD AND A MAGNET WAS TAPED TO THE CHEST. THE ACTUAL CAUSE OF DEATH IS UNKNOWN AND UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRUST AT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154ATG

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death 5076 IMPLANTABLE PACING LEAD