BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXATIP

    MDR report key: 1950542 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22831
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 13, 2010
    Report Date
    November 13, 2010
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED THEREFORE BOSTON SCIENTIFIC IS UNABLE TO CONFIRM THE CLINICAL OBSERVATIONS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS VENTRICULAR LEAD FRACTURED. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXATIP IMPLANTABLE LEAD NVN EXTERNAL MANUFACTURER 4162

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention 4171| 4162| 1294| 4457| S603| 4136| 0941| 1273