BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092981 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07309
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 4, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL WITH INCREASED SPASTICITY. AT THE FIRST PUMP REFILL, THE PUMP WAS VERY DIFFICULT TO ACCESS BECAUSE, IT WAS IMPLANTED SO DEEPLY UNDER THE SKIN. IT WAS BELIEVED THAT A DYE STUDY WAS ATTEMPTED AND THEY WERE UNABLE TO ASPIRATE FROM THE CAP. THERE WERE NO VOLUME DISCREPANCIES. THE PATIENT WAS ON THE SURGICAL SCHEDULE TO HAVE A REVISION ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT WAS DOING WELL UP UNTIL AFTER THE FIRST REFILL. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195577 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R