BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRINSIC

    MDR report key: 1823372 · Received September 2, 2010

    Report

    Report Number
    6000144-2010-04245
    Event Type
    Death
    Date Received
    September 2, 2010
    Date of Event
    February 28, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S041
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ASKU

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL OFF A LADDER AND "SUFFERED HEAD TRAUMA FROM WHICH HE EXPIRED." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. ADDITIONAL INFORMATION CONCERNING THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL OFF A LADDER AND "SUFFERED HEAD TRAUMA FROM WHICH HE EXPIRED." THE PHYSICIAN CONFIRMED HEAD TRAUMA AS THE CAUSE OF DEATH AND PHYSICIAN HAS NO SUSPICION OF DEVICE/LEAD MALFUNCTION OR ARRHYTHMIA. THE PATIENT HAD BEEN LOST TO FOLLOW UP AND HAD NOT BEEN SEEN AT THE CLINIC SINCE 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRINSIC ASKU LWS MEDTRONIC MED REL, INC. 7288 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O