BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1040498 · Received May 9, 2008

    Report

    Report Number
    2182207-2008-02511
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 10, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY DEVICE ANALYSIS RESULTS WERE NOT AVAILABLE ON THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED WITHDRAWAL SYMPTOMS FOR A WEEK THAT BEGAN A FEW DAYS FOLLOWING A REFILL IN 2008. THE PT'S PUMP WAS REPLACED TWELVE DAYS LATER. IT WAS INDICATED PREVIOUSLY, THAT A HEALTH CARE PROVIDER HAD TROUBLE WITH THE INTERROGATION PROCEDURE: TELEMETRY INCOMPLETE WHEN INTERROGATING IN A ROOM WITH AN X-RAY AND C-ARM. A ROLLER STUDY WAS PERFORMED BUT IT WAS UNK IF ANY PROBLEMS WERE FOUND AS THE STUDY WAS DONE AT ANOTHER FACILITY. IT WAS INDICATED THAT A PRIMING BOLUS OF 20 MCG OVER 1 MIN HAD BEEN PROGRAMMED IN AND THAT THE ROLLERS TURNED 50 DEGREES IN 1 HOUR. IT WAS ACKNOWLEDGED THAT THE PT HAD AN INTRAVENTRICULAR CATHETER AND THAT THE CATHETER IS IN THE VENTRICLES OF THE BRAIN. THE EVENT LOGS WERE OBTAINED AND NO STALLS WERE SHOWN. A DYE STUDY HAD NOT BEEN PERFORMED. A VOLUME CHECKED SHOWED NO DISCREPANCY. THE DRUG USED IN THE PUMP IS LIORESAL 2000 MCG/ML AT A DOSE OF 2000 MCG/DAY. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO 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 IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| CATHETER MODEL 8709 LOT# J11951R06| PROGRAMMER MODEL 8840 LOT# UNK