BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951495 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23105
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 25, 2010
    Report Date
    November 25, 2010
    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

    THE DEVICE AND RIGHT VENTRICULAR LEAD REMAIN IN SERVICE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS DETECTED DUE TO HIGH OUT OF RANGE SHOCK IMPEDANCES. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) WAS CONTACTED AND HAD NO FURTHER INFORMATION REGARDING THE OUTCOME. HE WILL BE CHECKING WITH THE CLINIC FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0137

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR E102| 0137