BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1083099 · Received July 24, 2008

    Report

    Report Number
    3004209178-2008-04256
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING A RETURN OF SYMPTOMS FOR THE PAST THREE WEEKS. A DYE STUDY WAS ATTEMPTED BUT THE HCP WAS UNABLE TO ASPIRATE CEREBROSPINAL FLUID FROM THE CATHETER. RESERVOIR VOLUMES WERE CHECKED; EXPECTED RESERVOIR VOLUME WAS 26.8 ML WHILE THE ACTUAL RESERVOIR VOLUME WAS 27.1 ML. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL DEVICE TROUBLESHOOTING WAS BEING CONSIDERED. THE PUMP CONTAINED BACLOFEN AND CLONIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED:| CATHETER MODEL #: 8709 LOT# N056043009| EXPLANTED: