BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1220421 · Received November 4, 2008

    Report

    Report Number
    6000030-2008-07186
    Event Type
    Injury
    Date Received
    November 4, 2008
    Report Date
    October 8, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET SITE MRSA INFECTION. THE PATIENT'S PUMP WAS EXPLANTED AND LATER REPLACED.

    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 59 YR Required Intervention CATHETER MODEL 8709| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER