BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3172566 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10430
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ¿PSYCHOTIC¿ EVER SINCE THE CATHETER WAS REPLACED, ABOUT SIX WEEKS PRIOR TO REPORT. THE REPORTER FELT THAT THERE WAS SOMETHING OBVIOUSLY WRONG, POSSIBLY RELATED TO THE BACLOFEN. IT WAS STATED THAT THE PATIENT WAS ¿STILL IN WITHDRAWAL¿, THOUGH IT WAS UNCLEAR IF THE REPORTER WAS REFERRING TO THE PRESENT OR REFERENCING THE PATIENT¿S PRIOR WITHDRAWAL. (REFER TO MANUFACTURER REPORT #3004209178-2013-07805 FOR DETAILS PERTAINING TO THE PATIENT¿S PRIOR WITHDRAWAL AND CATHETER REVISION.)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273860 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other