BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1213800 · Received October 22, 2008

    Report

    Report Number
    6000030-2008-06768
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    January 1, 2006
    Report Date
    September 23, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0956-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SEVERAL EPISODES OF WITHDRAWAL; 2006, AND 2007. THE PATIENT ALSO STATED THAT DURING THAT TIME, WHEN SHE WENT IN FOR A REFILL, ALL EXCEPT 2 MLS CAME OUT OF THE PUMP. THE PUMP WAS USED TO DELIVER MORPHINE. THE PATIENT STATED THE PLAN WAS TO REPLACE THE PUMP. 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 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR PROGRAMMER: MODEL PROGRAMMER| IMPLANTED:| CATHETER: MODEL 8709| EXPLANTED: