BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2010-23838

    MDR report key: 1953507 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23838
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE LEAD NOT BEING RETURNED ANALYSIS WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PULSE GENERATOR (PG) WAS EXPLANTED DUE TO AN INFECTION. THE DEVICE WILL NOT BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1