BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1994351 · Received January 14, 2011

    Report

    Report Number
    6000030-2011-00370
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    DURING A ROUTINE PUMP REPLACEMENT, THEY WERE UNABLE TO ASPIRATE FROM THE CATHETER. THE CATHETER HAD 4000 MCG/ML BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11748R30