BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO VR

    MDR report key: 1992250 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00340
    Event Type
    Death
    Date Received
    February 15, 2011
    Date of Event
    April 4, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S37
    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S FAMILY THAT THE PATIENT WOULD RECEIVE THERAPY AND IT WOULD CAUSE THE PATIENT TO FALL. PER THE FAMILY "THE DOCTOR TOLD ME THAT HER HEART WAS VERY WEAK AND THAT THE DEVICE IS KEEPING HER ALIVE. THE DOCTOR DID OFFER TO TURN IT OFF." IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE DEFIBRILLATOR SITE, THAT THE PATIENT BECAME WEAKER, MORE FRAIL AND DIED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7232CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death