BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3932637 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12976
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), EXPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS 1-2 MONTHS POST IMPLANT, A PROBLEM STARTED WITH THE PATIENT'S PUMP WHERE IT STARTED MOVING OUT OF THE POCKET. THE MOVEMENT BEGAN GRADUALLY. THE PATIENT HAD ALSO LOST SOME WEIGHT. THEY WERE UNSURE IF THE PUMP MOVEMENT WAS BECAUSE, THE HEALTHCARE PROFESSIONAL (HCP) DID NOT PLACE IT RIGHT, OR THE PATIENT LOST WEIGHT. THE PUMP WAS RESTING ON THE PATIENT'S HIP AND WAS AT THE SKIN LEVEL. THEY WERE UNABLE TO WEAR JEANS BECAUSE, THEY WOULD REST ON THE PUMP AND CAUSE PAIN. BASED ON THE HCPS REFILL TECHNIQUE, THEY THOUGHT THE PUMP WAS MOVING. THE HCP THOUGHT THE PUMP MIGHT BE PUSHING ITSELF OUT AND SUGGESTED THE PUMP BE SURGICALLY REPOSITIONED. THE PUMP WAS USED TO DELIVER BUPIVACAINE, BACLOFEN (UNKNOWN) AND MORPHINE. IT WAS FURTHER REPORTED, THE PUMP WAS TILTING AND CAUSED PAIN AROUND THE PUMP SITE. THE PUMP MOVEMENT WAS MOST LIKELY DUE TO THE PATIENTS WEIGHT LOSS. THE WEIGHT LOSS WAS "MOST LIKELY SECONDARY TO STRESS RELATED TO A DIVORCE". THE PUMP WAS NOT REPOSITIONED. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409317 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR