BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2760814 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08550
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 5, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED THAT FOR THE FIRST YEAR SHE FELL A LOT BECAUSE THE DOSE WAS TOO HIGH. SHE DAMAGED HER ARMS BECAUSE OF THIS. AFTER TITRATING THE DOSE DOWN, SHE HAD BEEN GETTING GOOD THERAPY FOR THE LAST YEAR UNTIL THE PUMP WENT EMPTY RECENTLY. PATIENT REPORTED A RETURN OF SYMPTOMS AFTER MISSING A REFILL ON (B)(6) 2012. AN ALARM WAS HEARD (GOING ON FOR 10 DAYS) TELEMETRY WAS NOT YET PERFORMED. THE PATIENT WAS ON A VERY LOW DOSE AND SHE HAD NOT EXPERIENCED REAL WITHDRAWAL, HOWEVER, SHE FELT DIFFERENT AND COULD TELL SHE WAS WITHOUT MEDICATION. SHE WAS REQUESTED TO GO TO THE EMERGENCY ROOM FOR A REFILL BUT LEFT WITHOUT ONE AFTER WAITING FOR SIX HOURS. THE PATIENT WAS SEEKING A PHYSICIAN TO MANAGE HER CARE. THE PUMP WAS DELIVERING BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1