BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1030854 · Received April 17, 2008

    Report

    Report Number
    2182207-2008-02014
    Event Type
    Injury
    Date Received
    April 17, 2008
    Report Date
    March 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP WAS IN "SAFE STATE", RESET OCCURRED, MOTOR STALL WITHOUT RECOVERY OCCURRED AND A "STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE WAS NOTED. THE PUMP LOGS ALSO SHOW A LOW BATTERY MESSAGE. THE PT EXPERIENCED UNSPECIFIED UNDERDOSE SYMPTOMS. THE PT WAS IN THE HOSPITAL IN SERIOUS CONDITION AND HAS HAD MULTIPLE MRI'S AND CT SCANS OVER THE PAST 6 WEEKS. THE PUMP CONTAINED MORPHINE 12 MG/ML, COMPOUNDED BACLOFEN 300 MCG/ML AND BUPIVICAINE 25 MG/ML. THE PT HAS BEEN SCHEDULED FOR PUMP REPLACEMENT 2008. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

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