BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 3012830 · Received March 20, 2013

    Report

    Report Number
    3007566237-2013-00838
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL NEU_UNKNOWN_CATH, SERIAL# UNK, IMPLANTED:UNK. PHYSICIAN PROGRAMMER: MODEL 8840, SERIAL# UNKNOWN, IMPLANTED:NA, EXPLANTED:NA. (B)(4).

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) RECEIVED AN ATTENTION DIALOGUE MESSAGE PUMP MEMORY ERROR (PME) CATHETER AND PUMP INFORMATION INVALID, DURING INTERROGATION OF THE PUMP WITH THE PHYSICIAN PROGRAMMER. IT WAS NOTED THAT THE PATIENT HAD A "NEW" PUMP AND CATHETER IMPLANTED "RECENTLY," AND THAT THE IMPLANTING HCP SUCCESSFULLY PROGRAMMED THE PUMP, WITH A DIFFERENT PHYSICIAN PROGRAMMER, THE DAY BEFORE THE INITIAL REPORT WAS MADE. THE PATIENT WAS CONCERNED THAT THE DOSAGE WAS "A LITTLE BIT TOO HIGH," WHICH WAS WHY THE PUMP WAS REPROGRAMMED. IT WAS UNKNOWN WHAT VERSION OF MEMORY CARD WAS IN THE PROGRAMMER WHEN THE PME APPEARED. LATER THAT DAY, IT WAS ADDED THAT THE PHYSICIAN WAS USING AN "OUT DATED" VERSION OF THE MEMORY CARD, A NEWER VERSION CARD REPLACED THE OLD VERSION AND THE ISSUE RESOLVED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE DEVICE SYSTEM WAS USED TO INFUSE LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114857 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR