BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2023079 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01413
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A RETURN OF SYMPTOMS WHICH INCLUDED VOMITING, WEAKNESS AND SPASTICITY. THE PT WAS TAKEN TO THE EMERGENCY ROOM. THE PT'S BLOOD AND URINE WERE TESTED, BUT NOTHING WAS FOUND. THEY THOUGHT THAT THE SYMPTOMS WERE RELATED TO THE PUMP. THEY HAD PLANNED TO CHECK THE PUMP. THE PT'S STATUS WAS STATED AS "FAIR". THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS BACLOFEN. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N269859002