BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242954 · Received November 21, 2008

    Report

    Report Number
    2182207-2008-07652
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HALF OF THE PATIENT'S PUMP WAS PROTRUDING OUT OF THE SKIN. THE MANUFACTURER'S DEVICE TRACKING SYSTEM INDICATES THE PUMP AND CATHETER WERE REPLACED. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention CATHETER MODEL 8709| PROGRAMMER: MODEL 8840| EXPLANTED: