BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2031563 · Received March 25, 2011

    Report

    Report Number
    3004209178-2011-02145
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 9, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS BECOMING LESS CLINICALLY RESPONSIVE TO THE BACLOFEN DOSING. ON (B)(6) 2011, IT WAS NOTED THAT THE PT HAD A "PSEUDOMENINGOCELE AT THE EXIT SITE FROM THE SPINE WHERE THE CATHETER ENTERS." THERE WAS FLUID COLLECTION NOTED AT THE BACK INCISION. THE CATHETER WAS EXPLANTED TO GIVE THE PSEUDOMENINGOCELE SEAL AN OPPORTUNITY TO HEAL AND A NEW CATHETER WAS PLACED ONE VERTEBRAL LEVEL ABOVE WHERE PSEUDOMENINGOCELE SITE EXISTED. THE NEW CATHETER WAS ATTACHED TO THE EXISTING PUMP. THE DEVICE SYS WAS USED TO DELIVER LIORESAL 500 MCG/ML AT 150 MCG/DAY. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT 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 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N272923010| EXPLANTED: