BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4805601 · Received May 29, 2015

    Report

    Report Number
    3004209178-2015-09943
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    June 21, 2014
    Report Date
    May 5, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8590-1, LOT# N143360, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8832, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MOTOR STALL ON 2014 (B)(6), WITH NO RECOVERY NOTED, BUT THAT THE PUMP HAD BEEN WORKING FINE SINCE THEN. SALINE HAD BEEN IN THE PUMP RESERVOIR SINCE 2011 AND THE PATIENT HAD BEEN MANAGED ON ORAL MEDICATIONS. ALL MEDICATIONS WERE TAKEN OUT OF THE PUMP 1.5 TO 2 YEARS AGO. IT WAS REPORTED THAT IN THE PAST, 9 DIFFERENT COMBINATIONS OF INTRATHECAL (IT) DRUGS WERE TRIED (FENTANYL, PRIALT, SUFENTANIL, MORPHINE, BUPIVACAINE AND CLONIDINE), AND THE THERAPY WAS NOTED AS PAIN PUMP THERAPY. THERE WERE NO PATIENT SYMPTOMS REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. [THERE WAS ADDITIONAL INFORMATION REPORTED THAT WAS NOT RELEVANT TO THIS EVENT AND THEREFORE WAS OMITTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349427 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR