BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2992728 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03447
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_PTM_PROG LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PERSONAL THERAPY MONITOR (PTM) HAD AN ERROR CODE AND THE PATIENT WAS UNABLE TO USE THEIR PTM. THE CODE INDICATED A PUMP MOTOR STALL OCCURRED. THERAPY WAS SUSPENDED AND AN EXTERNAL PUMP WAS INFUSING THROUGH THE CATHETER ACCESS PORT (CAP). THE ISSUE WAS NOTED TO BE ONGOING WITH NO FURTHER ACTION NEEDED. THE SEVERITY WAS NOTED TO BE MILD. THE PUMP SYSTEM WAS BEING USED TO DELIVER DILAUDID, BUPIVACAINE, CLONIDINE, BACLOFEN, AND KETAMINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DECISION WAS MADE TO SUSPEND THERAPY AND USE AN EXTERNAL PUMP. THE PHYSICIAN DID NOT HAVE ANY INTENTION OF REPLACING THE DEVICE, RESTARTING THERAPY, OR EXPLANTING THE DEVICE AS THE PATIENT WAS IN HOSPICE. TELEMETRY WAS NOT USED TO VERIFY THE MOTOR STALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98154 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR