BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2122196 · Received March 25, 2011

    Report

    Report Number
    3007566237-2011-01944
    Event Type
    Injury
    Date Received
    March 25, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PUMP CONTINUED TO STALL. THE PUMP WAS REPLACED. THERE WAS REPORTED TO BE NO OTHER PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LKK MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention