BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4223560 · Received November 4, 2014

    Report

    Report Number
    3004209178-2014-20894
    Event Type
    Injury
    Date Received
    November 4, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    A PUMP INFECTION WAS SUSPECTED BECAUSE THE PATIENT HAD HAD VERY UNEXPLAINED CONTINUED FEVERS. THEY WANTED TO ASPIRATE CSF (CEREBROSPINAL FLUID) TO TEST FOR INFECTION. IT WAS NOTED THAT THERE WERE NO AUDIBLE PUMP ALARMS. THE PUMP WAS CHECKED APPROXIMATELY 2 WEEKS PRIOR TO THIS REPORT. THE DEVICE SYSTEM WAS DELIVERING LIORESAL. THE INTERVENTIONS AND OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707216 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00019 YR Other