BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1952797 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24352
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH PACING THRESHOLDS. AN X-RAY WAS PERFORMED WHICH REVEALED THAT THE LEAD HAD PERFORATED THE PATIENT'S RV WALL AND ENTERED THE PLEURAL SPACE. A LEAD REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R 1782TC| H170| 0185| 4194| 4538| N119| MISMATCH| 6949