BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2193381 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05385
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED LETHARGY/SLEEPINESS FOLLOWING A CAP (CATHETER ACCESS PORT)/SPIRAL CT PROCEDURE. THE DRUG INFUSED WAS BACLOFEN CONC 2000 MCG/ML. THE NEXT DAY THE PT WAS DOING BETTER. THE RESULTS OF THE CAP/SPINAL CT WERE UNK YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCO 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N260372015| EXPLANTED: