BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3840612 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09891
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    September 17, 2013
    Report Date
    May 27, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8782, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8784, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8782, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8784, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2013 THAT THE PATIENT HAD POST-OPERATION SYMPTOMS OF A CEREBROSPINAL FLUID (CSF) LEAK. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT A VAILABLE AS OF THE DATE OF THIS REPORT. ADDITIONAL INFORMATION RECEIVED (B)(4) 2014 REPORTED THE PATIENT HAD SYMPTOMS OF PSEUDOMENINGOCELE WHICH REQUIRED WOUND REVISION AND SHUNT PLACEMENT. THE PATIENT WAS DOING WELL AS OF (B)(6) 2014 AND HAD NO SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319087 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR Required Intervention