BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1910646 · Received November 19, 2010

    Report

    Report Number
    6000030-2010-09793
    Event Type
    Injury
    Date Received
    November 19, 2010
    Report Date
    November 15, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT WAS "PARALYZED DUE TO THE PUMP"; SHE "HAS A POCKET OF MORPHINE" THAT WON'T GO AWAY. THE PT WAS NOT "BARELY WALKING" AND COULD NOT FIND A PHYSICIAN TO DISCUSS PUMP EXPLANT. THE PT WAS TOLD THAT THE CATHETER COULD NOT BE REMOVED DUE TO SCAR TISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U 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 Disability EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT # J0058128R