BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1862084 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-17858
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 28, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVLAUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD HAD BECOME DISLODGED. AT THE NORMAL BATTERY CHANGEOUT PROCEDURE FOR THE ASSOCIATED CRT-D, IT WAS OBSERVED THAT DEFIBRILLATION THRESHOLD TESTING (DFTS) WERE NOT SUCCESSFUL WITH THE ACUTE CRT-D. UNDER FLUOROSCOPY, IT WAS EVIDENT THAT THIS RV LEAD HAD DISLODGED. THE IMPLANTING PHYSICIAN SURGICALLY ABANDONED THIS LEAD AND PLACED AN ACUTE RV LEAD. IT WAS NOTED BY THE LOCAL AREA SALES REPRESENTATIVE THAT THE PATIENT RARELY PACES. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS AS A RESULT OF THE RV DISLODGEMENT.

    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 52 YR H177| 4047| 0158| 4087