BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170372 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09959
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXHIBITING CROSS-TALK ON THE VENTRICULAR CHANNEL WITH SOME PACING INHIBITION. THE PATIENT HAD MILD SYMPTOMS REPORTED. TECHNICAL SERVICES DISCUSSED PROGRAMMING OPTIONS TO ALLEVIATE THIS ISSUE.

    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 79 YR T125| 0158| 4469