BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRINSIC

    MDR report key: 1851205 · Received October 4, 2010

    Report

    Report Number
    6000144-2010-04283
    Event Type
    Death
    Date Received
    October 4, 2010
    Date of Event
    December 8, 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
    IN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. CAUSE OF DEATH WAS REQUESTED BUT NOT RECEIVED. THE DEVICE WAS NOT REMOVED AT THE TIME OF DEATH.

    Description of Event or Problem · 1

    THE PATIENT'S FAMILY REPORTED THAT THE PATIENT CODED DURING GALLBLADDER SURGERY AND NOW HAS BRAIN DAMAGE. STATED THE DEVICE DID NOT SHOCK HIM BECAUSE A MAGNET WAS OVER IT. FAMILY LATER REPORTED PT DIED BECAUSE HEART STOPPED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death