BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPORE

    MDR report key: 2051670 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03355
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 21, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS BECAUSE IT WAS CAPPED AND ABANDONED. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO INFECTION. IT WAS ALSO NOTED THE ASSOCIATED DEVICE WAS EXPLANTED DUE TO INFECTION. THE ASSOCIATED DEVICE IS A COMPETITOR'S PRODUCT. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPORE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 431-04

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR (B)(4)| (B)(4)| (B)(4)| 7108