BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASKU

    MDR report key: 1944505 · Received January 3, 2011

    Report

    Report Number
    2182208-2011-00002
    Event Type
    Death
    Date Received
    January 3, 2011
    Date of Event
    December 25, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PATIENT'S FAMILY MEMBER THAT THE PATIENT DIED ONE MONTH POST IMPLANT. IT WAS ALSO REPORTED THAT PATIENT HAD FELT DISCOMFORT FROM THE PACEMAKER AND THERE WAS "TRAUMA AROUND THE AREA WITH BLOOD FORMING AROUND THE UPPER SHOULDER AND ARM PIT AREA." THE FAMILY MEMBER FURTHER REPORTED THAT THE DEVICE HAD TO BE REPROGRAMMED MULTIPLE TIMES BECAUSE "HIS HEART WASN'T BEHAVING RIGHT." THE CAUSE OF DEATH HAS BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU IMPLANTABLE PULSE GENERATOR DTB MEDTRONIC, INC. IPG/MEDT ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R