BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203091 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00164
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    September 20, 2011
    Report Date
    February 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF A CEREBROSPINAL FLUID (CSF) LEAK. A SEROMA RELATIVE TO THE IMPLANTED SYSTEM WAS ASPIRATED. PATIENT SYMPTOMS FOLLOWING THE SEROMA ASPIRATION INCLUDED SWELLING AT THE LOWER BACK AND HEADACHE. APPROXIMATELY 2 MONTHS AFTER THE ASPIRATION A BLOOD PATCH INTERVENTION WAS PERFORMED AND SUCCESSFULLY TERMINATED THE CSF LEAK. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301252 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention