BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1844578 · Received September 23, 2010

    Report

    Report Number
    3007566237-2010-07216
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED PT HAD AN INFLAMMATORY MASS. IT WAS NOTED HCP TRIMMED THE CATHETER AND REPLACED THE INTRATHECAL END AND STARTED SAME INFUSION. THE PUMP CONTAINED CLONIDINE. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADD'L INFO WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER: MODEL CATHETER, LOT#: UNK| EXPLANTED:| IMPLANTED: