BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC III

    MDR report key: 1972016 · Received January 27, 2011

    Report

    Report Number
    6000094-2011-00017
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    August 15, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS UNRESPONSIVE AND EMERGENCY MEDICAL SERVICES WERE CALLED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE INITIAL RHYTHM WAS VENTRICULAR FIBRILLATION THAT WAS DEFIBRILLATED FIVE TIMES TO PULSELESS ELECTRICAL ACTIVITY. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM WITH NO PULSE OR RESPIRATIONS, AND REMAINED IN PULSELESS ELECTRICAL ACTIVITY. CPR WAS TERMINATED FOURTEEN MINUTES AFTER ARRIVAL TO THE ER AND THE PATIENT WAS PRONOUNCED DEAD. THE PHYSICIAN INDICATED THE CAUSE OF DEATH WAS MOST LIKELY ADVANCED ATHEROSCLEROTIC CORONARY ARTERY DISEASE. 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 NOTED THE PATIENT DIED APPROXIMATELY 8 MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS NOTED THE PATIENT DIED APPROXIMATELY 8 MONTHS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death