BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1040543 · Received May 9, 2008

    Report

    Report Number
    2182207-2008-02522
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT FELT ITCHING AND SCRATCHING FOR 1.5 WEEKS. HE HAD GONE TO THE EMERGENCY ROOM TWICE AND WAS GIVEN ORAL BACLOFEN. IN THE EMERGENCY ROOM, THE EXPECTED RESERVOIR VOLUME WAS 25 ML, BUT 30 ML WERE REMOVED. THERE WERE NO PUMP ALARMS; MULTIPLE X-RAYS WERE TAKEN THAT INDICATED THE PUMP WAS 'FINE' (DATE NOT REPORTED). THE PUMP WAS ALSO REPORTED TO BE FLIPPING AROUND. THE PT WAS AT HOME AND HIS STATUS WAS REPORTED AS 'FAIR'. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES LIORESAL. 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 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| CATHETER MODEL 8709| IMPLANTED| CATHETER MODEL 8596 LOT#N004014214| EXPLANTED| PROGRAMMER MODEL 8840 LOT#UNK| IMPLANTED