BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212496 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08310
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    January 2, 2013
    Report Date
    May 21, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK LEAD IMPEDANCE. (THE RIGHT VENTRICULAR DEFIBRILLATION LEAD MODEL AND SERIAL NUMBER IS UNKNOWN) NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD REVEALED HIGH SHOCKING IMPEDANCES GREATER THAN 200 OHMS. IN ADDITION, THE DEVICE ATTEMPTED TO DELIVER A SHOCK AND IT WAS UNKNOWN IF THE SHOCK WAS DELIVERED. THE DEVICE WAS INTERROGATED AND REPROGRAMMED FOR OPTIMIZATION. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AGENT WAS CONTACTED. THE AGENT DISCUSSED REPROGRAMMING OF THE DEVICE AND THAT THE SHOCK ENERGY WOULD STILL BE DELIVERED. IF THE PATIENT HAD INCORRECT PROGRAMMING ON THE SHOCK VECTORS THE MAY HAVE RESULTED IN A DAILY SHOCK IMPEDANCE GIVING OUT-OF-RANGE VALUES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314407 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening