BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1180995 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06186
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 29, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF EFFICACY THAT OCCURRED ABOUT 3 MONTHS AGO. THE PATIENT'S WIFE REPORTED HE HAD FALLEN 3 TIMES RECENTLY. IMPEDANCE CHECKS REPORTED RIGHT BRAIN IMPEDANCES WERE OVER 4000 OHMS<15UA. WHEN AMPLITUDES WERE CHANGED AND TESTED AT 4 VOLTS, THERE WERE TWO COMBINATIONS THAT WERE SIMILAR; ELECTRODES 4 & 5 AND 5 & 6 WERE 1883 OHMS. THE PATIENT WAS GETTING SOME EFFICACY. THE LEFT BRAIN IMPEDANCE WAS TESTED AND ALL PAIRS WERE 1395 OHMS<15UA. RETESTING AT 4 VOLTS AMPLITUDE SHOWED THE SAME RESULTS. MANUFACTURER'S REPRESENTATIVE SUGGESTED PALPATING AND X-RAY. ADDITIONALLY, IT WAS NOTED THE PATIENT HAD A BURR HOLE REMOVED TWO WEEKS PRIOR. NO ADDITIONAL SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| LEAD: MODEL 3387| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7436| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387| IMPLANTED:| EXTENSION: MODEL 7482