BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3768118 · Received April 23, 2014

    Report

    Report Number
    3004209178-2014-07852
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. PRODUCT ID: 85 90-1, LOT# N380771, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8870, SERIAL# UNKNOWN, PRODUCT TYPE: SOFTWARE. PRODUCT ID: 8840, SERIAL# UNKNOWN. : PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPORTER EXPERIENCED A PUMP MEMORY ERROR (PME). IT WAS STATED THAT THE PATIENT WAS RECENTLY IMPLANTED AND THIS WAS THE FIRST TIME THE PATIENT WAS SEEN. THE REPORTER WANTED TO PERFORM A DOSING ADJUSTMENT AND UPON INTERROGATION THE PME WAS SEEN, ALONG WITH INVALID CATHETER INFORMATION. IT WAS DISCUSSED THAT THE VERSION OF THE SOFTWARE CARD USED DID NOT RECOGNIZE THE CATHETER AND THAT THE NEWER VERSION OF THE SOFTWARE CARD WAS NEEDED. IT WAS RECOMMENDED TO DOCUMENT THE CATHETER MODEL, TOTAL CATHETER LENGTH (TCL), AND TOTAL CATHETER VOLUME (TCV) TO ENTER IN A LATER DATE WITH THE NEWEST SOFTWARE CARD. SINCE THE PATIENT COULD NOT WAIT LONG (PRESUMABLY FOR A MANUFACTURER REPRESENTATIVE) DUE TO LIVING IN A DIFFERENT STATE, IT WAS SUGGESTED TO CHANGE THE CATHETER INFORMATION TO ¿OTHER¿ AND ENTER THE DOCUMENTED TCV. THE REPORTER DENIED ANY THERAPY ISSUES AT THIS TIME. THE PUMP WAS USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247179 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR