BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3972744 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13800
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED SPASTICITY AND UNDERDOSE SYMPTOMS INCLUDING LESS THAN 50% THERAPY RELIEF. A CATHETER ISSUE WAS REPORTED. TROUBLESHOOTING AND DIAGNOSTIC TESTING WAS PERFORMED INCLUDING A DYE STUDY, X-RAYS AND LOGS WERE CHECKED. THE SPECIFIC CATHETER ISSUE AND LOCATION OF THE ISSUE WERE UNABLE TO BE DETERMINED. THE PATIENT REQUIRED HOSPITALIZATION AND THE CATHETER WAS REVISED. THE OLD CATHETER HAD CEREBROSPINAL FLUID (CSF) FLOW. THE OLD CATHETER WAS TIED OFF AND A NEW CATHETER WAS IMPLANTED. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. THE PUMP WAS DELIVERING LIORESAL. ADDITIONAL INFORMATION REPORTED THE CATHETER WAS DRIPPING CEREBROSPINAL FLUID (CSF). IT WAS UNKNOWN WHAT WAS WRONG OR IF THERE COULD HAVE BEEN A MICRO FRACTURE. AN UPDATE ON THE PATIENT¿S STATUS WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450619 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R