BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2910914 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15957
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Product Problem
    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 THIS LEAD WAS SCHEDULED FOR EXTRACTION DUE TO INFECTION. ADDITIONALLY, THERE WAS CLEAR INSULATION DAMAGE FROM WHEN THE DEVICE WAS RECENTLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18501 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0144

    Patients

    Seq Age Sex Outcome Treatment
    1