BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2062475 · Received April 12, 2011

    Report

    Report Number
    6000030-2011-02763
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 30, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0589-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AT THE SCHEDULED REFILL VISIT, THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME; THE PUMP STILL HAD 18 CC OF DRUG. THE PUMP WAS FILLED MONTHLY. AT THE LAST REFILL, THE VOLUMES MATCHED. IT WAS NOTED THAT THE PT HAD AN MRI PRIOR TO GETTING THE PUMP FILLED THE LAST TIME. SINCE THEN, THE PT HAD HAD UNDERDOSE SYMPTOMS. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CATHETER: MODEL 8731, LOT# B005111N53| IMPLANTED:| EXPLANTED: