BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2172585 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-05613
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A CATHETER WAS CONFIRMED AS BEING DISLODGED. A REVISION WAS PERFORMED ON (B)(6) 2011, AND A NEW CATHETER WAS PLACED. IT WAS LATER REPORTED THAT THE PT'S TRIAL WAS NOTED AS BEING GREAT WITH A REDUCTION IN TONE; HOWEVER THERE WAS NO IMPROVEMENT POST IMPLANT. THE PT'S PUMP WAS IMPLANTED ON (B)(6) 2011. A CATHETER ACCESS PORT TEST AND AN X-RAY HAD BEEN PERFORMED. THE PT'S OUTCOME WAS REPORTED AS BEING UNK. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention CATHETER: MODEL 8711, LOT# N270166015| IMPLANTED:| EXPLANTED: