BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200335 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11149
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8840, SERIAL# UNKNOWN. PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED BACLOFEN OVERDOSE SYMPTOMS. THE DOSE WAS ¿TAKEN UP TOO HIGH¿ IN (B)(6) 2012. THE PATIENT WAS RECEIVING 125 MCG A DAY AT THAT TIME AND IT WAS NOTED ¿WHICH ISN¿T A WHOLE LOT. BUT IT WAS JUST TOO MUCH. AND IT WENT FROM 125 TO 100 DOWN TO 75 MCG A DAY¿. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298673 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Other