BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 2760965 · Received September 26, 2012

    Report

    Report Number
    2649622-2012-12840
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 12, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 LEAD IMPEDANCE HAD INCREASED AND THAT NO R-WAVES WERE SHOWING ON THE ELECTROGRAM. THE LEAD WILL CONTINUE TO BE MONITORED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN 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. 5071

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other ADDR01 IMPLANTABLE PULSE GENERATOR| 4951M IMPLANTABLE PACING LEAD