BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3282053 · Received August 12, 2013

    Report

    Report Number
    3004209178-2013-14462
    Event Type
    Malfunction
    Date Received
    August 12, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. PRODUCT ID: 8870, PRODUCT TYPE: SOFTWARE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP MEMORY ERROR OCCURRED DURING A PUMP UPDATE. IT WAS STATED THAT THE PHYSICIAN PROGRAMMER CONTAINED AN ¿AAJ¿ SOFTWARE CARD, THOUGH THE HEALTHCARE PROFESSIONAL HAD OTHER PROGRAMMERS AVAILABLE. THE PATIENT¿S DEVICE SYSTEM WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385663 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR