BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2124215-2011-10398

    MDR report key: 2172870 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10398
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC 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. NO PATIENT INFORMATION REGARDING NAME OR MODEL/SERIAL NUMBER WAS PROVIDED.

    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 Life Threatening| R