BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 1863656 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15843
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    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 76 YR Required Intervention 4269| 4261| 1230| (B)(4)