BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2802599 · Received October 24, 2012

    Report

    Report Number
    3004209178-2012-09453
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT # J10999R01, IMPLANTED: (B)(6) 2002, PRODUCT TYPE CATHETER; PRODUCT ID 8598A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8578, LOT # N148370, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT. THE PATIENT HAD A LOSS OF FEELING IN BOTH OF THE LEGS FOLLOWING A REFILL SESSION. THE PHYSICIAN DID TWO MRI'S AND RULED OUT AN INFLAMMATORY MASS. IT WAS BELIEVED THE CONCENTRATION MAY BE INCORRECT SO THEY WERE GOING TO CHANGE OUT THE DRUG. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (B)(6) 2012. THE DRUG WAS DILUTED BY 50% AND THE DOSE WAS DECREASED FROM 10MG-7.5MG/DAY. AS OF (B)(6) 2012, THE PATIENT WAS STILL IN THE HOSPITAL AND WAS BEING MONITORED FOR ANY CHANGES IN SYMPTOMS. THE PUMP WAS DELIVERING FENTANYL, BUPIVACAINE, BACLOFEN AND DILAUDID.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R