BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3250930 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12381
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 16, 2013
    Report Date
    July 1, 2013
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013 FOR WITHDRAWAL. THE PUMP WAS REPLACED ON (B)(6) 2013 AND AS OF THE REPORT DATE, THE PATIENT WAS ¿DOING GREAT¿. THE REPORTER WAS NOT AWARE OF ANY TROUBLESHOOTING THAT WAS PERFORMED. THEY DID GET GOOD CSF BACK FLOW WHEN THEY REPLACED THE PUMP AND THE ORIGINAL CATHETER WAS LEFT INTACT. THE PUMP DEVICE WAS USED TO DELIVER BACLOFEN, DILAUDID, BUPIVICAINE AND FENTANYL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP STOPPED WORKING AND THE PATIENT STARTED EXPERIENCING WITHDRAWAL SYMPTOMS. THE PATIENT¿S PAIN WAS ¿REALLY BAD¿. THE PUMP STILL HAD 11 MONTHS OF LIFE LEFT WHEN THE INCIDENT OCCURRED. AT THE TIME OF THE REPORT, THE PATIENT WAS GETTING GOOD THERAPY. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID 10MG/ML AT 3.849MG/DAY, FENTANYL 2000MCG/ML AT 769.8MCG/DAY, BUPIVACAINE 30MG/ML AT 11.547MG/DAY AND BACLOFEN 215MCG/ML AT 82.37MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352409 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Hospitalization| R