BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYNC III

    MDR report key: 1922333 · Received December 13, 2010

    Report

    Report Number
    6000094-2010-02199
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 10, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    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 DEVICE IS PACING INAPPROPRIATELY BY NOT INHIBITING. IT WAS NOTED THAT THE PHYSICIAN PUT A VENTRICULAR LEAD IN AND PLUGGED IT IN THE ATRIAL PORT WHICH IS OFF LABEL USE. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD