BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1182664 · Received September 25, 2008

    Report

    Report Number
    3004209178-2008-06133
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    August 3, 2008
    Report Date
    September 2, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS EXPERIENCING A RETURN OF SYMPTOMS AND BREAKTHROUGH PAIN. IT WAS ALSO REPORTED THE PT FELL IN 2008, AND SINCE THE FALL HAS GAINED 6 POUNDS. THE PT HAS AN INTRATHECAL DRUG DELIVERY PUMP IMPLANTED TO TREAT CHRONIC PAIN. IT IS UNK WHAT DRUG IS USED IN THE PUMP. 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 PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention CATHETER: MODEL 8711| CATHETER: MODEL 8596| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840