BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1860441 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15042
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 29, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESOLUTION WAS REQUESTED FROM THE FIELD REPRESENTATIVE, HOWEVER, AS OF TODAY NO FURTHER INFORMATION HAS BEEN RECEIVED. INFORMATION SUGGEST THESE PRODUCTS REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    RESOLUTION WAS REQUESTED FROM THE FIELD REPRESENTATIVE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EVALUATED. THERE WERE NO STORED EPISODES AND NO PROGRAMMING CHANGES. THE PATIENT IS SCHEDULED FOR NORMAL 3 MONTH FOLLOW-UPS. INFORMATION SUGGEST THESE PRODUCTS REMAIN IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND DEFIBRILLATION LEAD REPORTED FEELING SMALL SHOCKS EVERY HOUR OR SO. THE PATIENT WAS TOLD IN THE EMERGENCY ROOM THAT THERE WAS A BROKEN LEAD. THE PATIENT ALSO REPORTS FEELING PAIN AT THE BOTTOM OF THE DEVICE. TECHNICAL SERVICES ADVISED THAT THE PATIENT FOLLOW UP WITH THEIR PHYSICIAN. NO FURTHER EFFECTS WERE REPORTED.

    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 67 YR 4136| 6936| MISMATCH| 6986| 1860| 0158| T127