BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2844858 · Received November 26, 2012

    Report

    Report Number
    2649622-2012-17472
    Event Type
    Death
    Date Received
    November 26, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. FOR USE BY USER FACILITY/IMPORTER (DEVICES ONLY). (B)(4). IMPLANTABLE CARDIAC DEFIBRILLATOR 2012 (B)(6). THE LEAD WAS NOT RETURNED TO THE MANUFACTURER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS DECEASED AND DIED THREE DAYS POST IMPLANT OF IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death 4196 IMPLANTABLE PACING LEAD