BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1083091 · Received July 24, 2008

    Report

    Report Number
    2182207-2008-04268
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    March 6, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING A RETURN OF SYMPTOMS. A MOTOR STALL WAS NOTED IN THE EVENT LOGS WITH NO MOTOR STALL RECOVERY RECORDED. THE STALL OCCURRED IN 2008. A "STOPPED PUMP MAY EXCEED TUBE SET" MESSAGE WAS ALSO NOTED ON THE SAME DAY. THE PHYSICIAN UPDATED THE PUMP AND NO RECOVERY WAS NOTED ON THE LOGS. NO DIAGNOSTIC STUDIES HAD BEEN PERFORMED. THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    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 10 YR Required Intervention PROGRAMMER MODEL 8840 LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| CATHETER MODEL 8709 LOT# J10870R15