BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950672 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24405
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE. THE INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), DID APPEAR TO EXHIBIT RV LOSS OF CAPTURE (LOC). TO DATE, INTERVENTION HAS NOT BEEN PERFORMED. THERE WERE NO ADVERSE PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. THE LOCAL AREA SALES REPRESENTATIVE COULD NOT CONFIRM NOR DENY THIS INFORMATION AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)