BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK PLUS

    MDR report key: 1861102 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15432
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW DEFIBRILLATION LEAD WAS SUCCESSFULLY IMPLANTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A NORMAL DEVICE CHANGE OUT PROCEDURE, THIS DEFIBRILLATION LEAD WAS CAPPED. WHEN THE LEAD WAS REMOVED FROM THE DEVICE, IT WAS NOTED THAT THE RATE/SENSE PORTION WAS FRACTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK PLUS IMPLANTABLE LEAD NVY HISTORICAL PUERTO RICO 0075

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 0184| 0075| 1788| 1720| E102| T135