BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 700 DR

    MDR report key: 1861637 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04775
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE UNABLE TO ESTABLISH TELEMETRY, EVEN THOUGH THE PROGRAMMER WORKED JUST FINE EARLIER WITH A DIFFERENT PATIENT. THE DEVICE 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
    1 KAPPA 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR701 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other 4074 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD