BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1222416 · Received November 5, 2008

    Report

    Report Number
    3004209178-2008-07202
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    August 1, 2008
    Report Date
    October 8, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INCREASED PAIN. AN X-RAY (2008) REVEALED THAT THE CATHETER POSITION WAS UNCHANGED. THREE DAYS LATER THE PUMP WAS ASPIRATED AND THE VOLUMES WERE FOUND TO BE ACCURATE. A DOSE ADJUSTMENT WAS DONE WITH DECREASED PAIN. A CATHETER DYE STUDY WAS PLANNED, AND THEN ABORTED WHEN CSF WAS EASILY ASPIRATED. THE PT CONTINUED TO EXPERIENCE LACK OF EFFECT IT WAS REPORTED THAT THE PT WAS "NOT ANY BETTER SINCE SURGERY" AND STILL USED A CANE TO WALK. THE PT EXPERIENCED SCIATICA SECONDARY TO CATHETER IRRITATION. THE PT'S CATHETER WAS REPLACED. THE PT OUTCOME WAS REPORTED AS NO INJURY. THE PT'S PUMP CONTAINED A MORPHINE/BUPIVACAINE MIXTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention PROGRAMMER: MODEL 8840| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC