BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2801437 · Received October 23, 2012

    Report

    Report Number
    3007566237-2012-02497
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERWENT A "REPOSITIONING SURGERY" FOR HIS LEFT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) IN FEB-2011. IT WAS NOTED THAT THE PATIENT HAD SOME IMPROVEMENT IN HIS SYMPTOMS, BUT WAS EXPERIENCING MIXED RESULTS. IT WAS FURTHER NOTED THAT THE PATIENT HAD NOT "FOUND PROGRAMMING CHANGINGS THAT HAVE A SATISFACTORY BALANCE." THE PATIENT OUTCOME WAS NOT PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. REFER TO MANUFACTURING REPORT #3007566237-2012-02496.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention