BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242951 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-07664
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 27, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A LOSS OF BACLOFEN EFFECT WITH HIGH DOSE OF BACLOFEN (GREATER THAN 900 MCG/DAY). THE PUMP AND CATHETER WERE REPLACED IN 2008. IT WAS NOTED THAT THERE WAS CONCERN REGARDING INTERMITTENT MALFUNCTION BECAUSE NO CATHETER PROBLEM WAS FOUND WHEN THE CATHETER WAS REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention CATHETER: MODEL 8709| EXPLANTED| PROGRAMMER: MODEL 8840