BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II DR

    MDR report key: 2230038 · Received August 31, 2011

    Report

    Report Number
    2647346-2011-01139
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    July 2, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND FOUND TO HAVE NORMAL BATTERY DEPLETION. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND FOUND TO HAVE NORMAL BATTERY DEPLETION. ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY THREE MONTHS POST OF THE SYSTEM. ADDITIONAL INFORMATION RECEIVED INDICATED THE CAUSE OF DEATH WAS CARDIAC ARREST. THE PATIENT WAS FOUND AT HOME UNRESPONSIVE, EMERGENCY MEDICAL SERVICES WERE CALLED. THE PATIENT WAS IN ASYSTOLE AND UNABLE TO BE REVIVED. THE PATIENT WAS NOT PACEMAKER DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| L| R