BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-23383

    MDR report key: 1952146 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23383
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHONIZATION THERAPY DEFIBRILLATOR (CRT-D), LEFT VENTRICULAR (LV), RIGHT ATRIAL (RA), AND RIGHT VENTRICULAR (RV) LEADS WERE EXPLANTED DUE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NVY GUIDANT PUERTO RICO BV TACHY LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1