BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 900 DR

    MDR report key: 1922796 · Received December 13, 2010

    Report

    Report Number
    2647346-2010-00840
    Event Type
    Malfunction
    Date Received
    December 13, 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
    RI, 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

    THE PATIENT REPORTED "HAVING HOT TWINGES IN MY HEART", AND INQUIRED WHETHER IT COULD BE CAUSED BY THE DEVICE. THE DEVICE 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 KAPPA 900 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR901 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other 4592 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD