BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

    MDR report key: 2955637 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02420
    Event Type
    Death
    Date Received
    February 11, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). THE LEAD HAS NOT BEEN RETURNED TO THE MANUFACTURER AND WILL NOT BE EVALUATED.

    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 DURING THE IMPLANT PROCEDURE THE PATIENT'S BLOOD PRESSURE DROPPED AND TAMPONADE WAS SUSPECTED. IT WAS ALSO NOTED THAT A CARDIAC WINDOW WAS PERFORMED AND THE PATIENT DIED WHILE IN THE SURGICAL SUITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58180 DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M55

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Death