BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170330 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10060
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOSS OF CAPTURE (LOC). A X-RAY WAS PERFORMED, AND REVEALED THIS RV LEAD HAD DISLODGED. A REPOSITIONING PROCEDURE WILL TAKE PLACE IN THE NEAR FUTURE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THIS RV LEAD WAS REPOSITIONED, AND ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0285

    Patients

    Seq Age Sex Outcome Treatment
    1