BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1213295 · Received October 27, 2008

    Report

    Report Number
    2182207-2008-06897
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S INTRATHECAL DRUG DELIVERY PUMP WAS SUSPECTED TO BE FLIPPED. THE PATIENT WAS EXPERIENCING A RETURN OF SYMPTOMS (INCREASED SPASTICITY). AN MRI AND X-RAY WERE PERFORMED TO DETERMINE IF THE PUMP WAS FLIPPED. FOLLOWING THE MRI, THE PUMP WAS NOTED TO HAVE STALLED. EVENT LOGS FROM THE PUMP WERE PRINTED. A STALL OCCURRED AT 11:00 AND A RECOVERY OCCURRED AT 12:35. FOLLOW UP INDICATED THE PHYSICIAN WAS UNABLE TO TELL FOR SURE IF THE PUMP WAS FLIPPED AFTER THE DIAGNOSTIC TESTING. IT WAS THOUGHT THAT IT WAS FLIPPED AND HAD CAUSED THE CATHETER TO KINK. EXPLORATORY SURGERY WAS SCHEDULED FOR 2008. 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 Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8575| IMPLANTED:| CATHETER: MODEL 8709| EXPLANTED:| PROGRAMMER: MODEL 8840