BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2141135 · Received June 22, 2011

    Report

    Report Number
    6000030-2011-04667
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    September 20, 2010
    Report Date
    May 26, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PRIMARY ANALYSIS FINDING WAS NO ANOMALY FOUND - NORMAL DEVICE FUNCTION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THAT A CATHETER THAT HAD BEEN EXPLANTED ON (B)(6) 2010, WAS FOUND TO HAVE BEEN DISLODGED WHICH WAS LEADING TO INCREASING DOSES AND POOR PAIN CONTROL. THE SYSTEM WAS REPLACED ON (B)(6) 2010. DILAUDID HAD BEEN USED IN THE PUMP. NO HOSPITALIZATION WAS REPORTED, AND THE OUTCOME WAS RECOVERED WITHOUT SEQUELAE. ADD'L INFO WILL BE REPORTED IF IT 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 48 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8711, LOT# J11405R43| IMPLANTED: