BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP

    MDR report key: 1954203 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24712
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO ALLEGATION AGAINST DEVICE FUNCTIONALITY. THIS LEAD WAS EXPLANTED SECONDARY DUE TO POCKET INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED SECONDARY DUE TO POCKET INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention 4269| 7952