BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041716 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01581
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    December 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED ADDITIONAL OUT OF RANGE MEASUREMENTS HAD BEEN RECORDED. THE LOCAL FIELD REPRESENTATIVE INDICATED THAT THE LEAD WOULD CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS RIGHT VENTRICULAR (RV) LEAD AND THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. OUR RECORDS INDICATE THAT THIS LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR MISMATCH| 0180| E110| 1290