BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1863725 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15888
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT, THIS DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED. A NEW LEAD WAS IMPLANTED. THE DEVICE WAS ELECTIVELY REPLACED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DETECTED A LOSS OF CAPTURE ON THIS DEFIBRILLATION LEAD. 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 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 0157| 4135| E110| 0184| E102