BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1203219 · Received October 17, 2008

    Report

    Report Number
    2182207-2008-06668
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 17, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - CATHETER.

    Description of Event or Problem · 1

    THE PATIENT WAS EXPERIENCING ABDOMINAL PAIN, ALTERED MENTAL STATUS AND A DECREASED HEART RATE; THERE WAS NO INCREASE IN SPASTICITY. THE PATIENT HAD RECENTLY HAD A PACEMAKER IMPLANTED (DATE NOT REPORTED). THE PATIENT'S PUMP WAS CHECKED FOR VOLUME DISCREPANCIES, THE RESULTS SHOWED MINIMAL DIFFERENCES (WITHIN FLOW RATE ACCURACY) IN THE ACTUAL AND EXPECTED VOLUMES. A CATHETER DYE STUDY WAS ATTEMPTED, BUT THE RADIOLOGIST WAS UNABLE TO ASPIRATE ANY CEREBROSPINAL FLUID. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| EXPLANTED:| IMPLANTED: