BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 2053126 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05784
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K940703
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD WARNING OCCURRED, THERE WAS LOW IMPEDANCE AND A POSSIBLE ISSUE WITH THE LEAD'S INSULATION. IT WAS ALSO REPORTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT AND THERE WAS A LOT OF TROUBLE MAINTAINING TELEMETRY WITH THE DEVICE. THE LEAD AND DEVICE REMAIN IN USE. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4558M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other 4024 IMPLANTABLE PACING LEAD