BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151149 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06171
    Event Type
    Death
    Date Received
    July 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    August 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT HAD DIED. THE PATIENT WAS TRANSFERRED TO HOSPICE CARE AND DIED EIGHT DAYS AFTER THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), ATRIAL LEAD, AND RIGHT AND LEFT VENTRICULAR LEADS HAD PROBLEMS WITH THE HEALING OF THEIR DEVICE POCKET. IT WAS REPORTED THAT THE PATIENT WAS VERY THIN. THE REPRESENTATIVE LATER REPORTED THAT THIS PATIENT DEVELOPED (B)(6) AND A (B)(6). THE PHYSICIAN ATTEMPTED TO CLEAN THE WOUND AND LEFT THE LEADS IMPLANTED. THE ATRIAL AND LEFT VENTRICULAR LEADS WERE SURGICALLY ABANDONED. THE PATIENT RECEIVED A SINGLE-CHAMBER PACEMAKER AS THIS PATIENT WAS DEVICE DEPENDANT. THE DEVICE WAS PUT IN THE POCKET BUT THE POCKET WAS LEFT OPEN. ONCE THE INFECTION CLEARS THE PATIENT WILL BE UPGRADED TO ANOTHER BI-VENTRICULAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| R H175| 4087| 4513| 0158| H135| N118