BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 3152460 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01553
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    PMA / PMN Number
    K844974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAS DECREASING IMPEDANCE, LOW IMPEDANCE, NOISE AND A POSSIBLE INNER INSULATION BREACH. THE LEAD IS STILL 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
    253066 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC 4012

    Patients

    Seq Age Sex Outcome Treatment
    1