BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 DR

    MDR report key: 1925297 · Received December 14, 2010

    Report

    Report Number
    2647346-2010-00867
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/014
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    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 PATIENT "FEELS FUNNY, HEART GOING FAST", WHEN DRIVING OFF-ROAD USING THE LEFT ARM. THE PATIENT ALSO REPORTED FEELING "THE PACEMAKER GOING FASTER AND THEN A PAUSE, THEN FAST AGAIN", AND "A SORT OF VIBRATING IN LEFT PECTORAL AREA AND IN STOMACH AREA". THE DEVICE REMAINS 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 KAPPA 900 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR906 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other 6957J IMPLANTABLE PACING LEAD| 49303 COMPETITOR IMPLANTABLE PACING LEAD