BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4140293 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-18285
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 9, 2014
    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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT¿S GUARDIAN REPORTED POOR SPASTICITY CONTROL SINCE THE PUMP WAS IMPLANTED. THEIR DOSE HAD BEEN INCREASED REPEATEDLY. THE PUMP LOGS WERE CHECKED, X-RAYS WERE PERFORMED, A ROTOR/ROLLER STUDY WAS PERFORMED, AND A DYE STUDY WAS PERFORMED. THE CATHETER APPEARED INTACT IN FLUOROSCOPY, AND THE ROTOR MOVED AS EXPECTED. THE PUMP LOGS REVEALED NO ISSUES. A HEALTHCARE PROFESSIONAL (HCP) WAS UNABLE TO ASPIRATE CEREBROSPINAL FLUID (CSF) FROM THE CATHETER ACCESS PORT (CAP). THE PATIENT¿S STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. AS OF (B)(6) 2014 THERE WAS NO CHANGE IN THE PATIENT¿S TREATMENT PLAN, AND NO FURTHER INTERVENTIONS WERE TAKEN. THE PUMP CONTAINED BACLOFEN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT NEVER RECEIVED EFFECTIVE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED. (SEE MANUFACTURER REPORT # 3004209178-2015-04319 WHICH CAPTURES THE ULTIMATE REASON THE CATHETER WAS ADDRESSED SURGICALLY-INFECTION.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618424 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR