BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2173816 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-12160
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 A SYSTEM REVISION WAS PENDING DUE TO INFECTION FOR A PATIENT WITH THIS MODEL LEAD. THERE WAS NO ADDITIONAL INFORMATION IMMEDIATELY AVAILABLE. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE HAS BEEN CONTACTED TO TRY TO IDENTIFY THE PRODUCTS AND OBTAIN ANY ADDITIONAL INFORMATION REGARDING THEIR STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention