BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1222414 · Received November 5, 2008

    Report

    Report Number
    3004209178-2008-07205
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED DECREASED THERAPEUTIC EFFICACY. A SIDE PORT TAP WAS UNSUCCESSFUL IN WITHDRAWING FLUID. THE CATHETER WAS REPLACED. THE PT RECOVERED WITHOUT SEQUELA. THE PT'S PUMP CONTAINED BACLOFEN 2000 MCG/ML DELIVERED AT 442.7 MCG/DAY.

    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 19 YR Required Intervention CATHETER: MODEL 8709SC| PROGRAMMER: MODEL 8840| IMPLANTED:| EXPLANTED: