BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 1851245 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14719
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT HAD TWIDDLER'S SYNDROME AND HAD TWIDDLED THE RIGHT VENTRICULAR (RV) LEAD . THE RV LEAD ALSO EXHIBITED HIGH THRESHOLD MEASUREMENTS, SO IT WAS SURGICALLY ABANDONED. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4261

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R S201| 0460| 4261| 4136| 1180