BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202646 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-02542
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 14, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DRUG RESERVOIR WAS TO BE FILLED (B)(6) 2012, BUT THE ¿DOCTOR WOULDN¿T FILL IT¿. THE HCP REDUCED THE DOSAGE, AND THE PATIENT REPORTED FEELING ¿REALLY SICK¿. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302674 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR