BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IROX

    MDR report key: 4131689 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15088
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    PMA / PMN Number
    K890412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    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 DURING THE EXPLANT OF THIS PATIENT'S PACEMAKER FOR NORMAL BATTERY DEPLETION (NBD) THIS LEAD WAS FOUND TO BE STUCK IN THE DEVICE HEADER. THE LEAD WAS DAMAGED IN AN ATTEMPT TO FREE IT FROM THE DEVICE, AND WAS UNABLE TO BE RE-USED. THE LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612144 IROX IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 430-07

    Patients

    Seq Age Sex Outcome Treatment
    1 1204 MO MISMATCH| K063| 430-07| 4136| 1298| 1283| 294-05