BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHROMED EL.

    MDR report key: 539333 · Received August 11, 2004

    Report

    Report Number
    6000030-2004-01029
    Event Type
    Other
    Date Received
    August 11, 2004
    Report Date
    July 20, 2004
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NCP REPORTS THE PT HAS BEEN RECEIVING RADIATION TREATMENT (APPROXIMATELY 800 RADS) BEHIND THE LOCATION OF THE PUMP. A PUMP MEMORY OCCURRED AND THE PUMP IS UNABLE TO BE UPDATED. HCP REPORTS THERE IS ONE RADIATION TREATMENT LEFT. ONCE COMPLETE THE PUMP WILL BE EXPLANTED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other EXP: UNK.| CATHETER: MODEL 8709AA, LOT# J11805R07, IMP: 2004,