BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1852632 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14249
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION WAS PERFORMED AND THIS LEAD WAS SUCCESSFULLY REPLACED WITH AN ACTIVE FIXATION DEFIBRILLATION LEAD. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT SEVERAL DAYS AFTER THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS IMPLANTED, THE THRESHOLDS INCREASED TO ABOVE 7 VOLTS AND THERE WAS LOSS OF CAPTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1