BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3112054 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-04791
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    June 26, 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

    PRODUCT ID: 8709SC LOT# N184776001, IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PUMP WAS FLIPPING. THE PUMP WAS REVISED. IT WAS BELIEVED THE PATIENT WAS DOING WELL POST REVISION.

    Description of Event or Problem · 1

    A PROBLEM WAS REPORTED REGARDING A PUMP. PATIENT REPORTED TO HAVE A PAIN PUMP FOR CERVICAL DYSTONIA. PUMP WAS PLACED IN (B)(6) 2009 AND SHE HAD TO HAVE IT FIXED IN (B)(6) 2011 BECAUSE IT STARTED MOVING AGAIN. PATIENT INDICATED SHE HAD SURGERY 3 TIMES, ONCE TO PLACE THE PUMP AND 2 TIMES TO FIX IT AND SHE WAS GOING TO HAVE TO HAVE ANOTHER. A FOLLOW UP WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS RECEIVED AS OF THE TIME OF THIS REPORT. SYSTEM USED TO DELIVER BACLOFEN(UNKNOWN). IF ADDITIONAL INFORMATION BECOMES AVAILABLE A REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212741 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention