BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3181965 · Received June 21, 2013

    Report

    Report Number
    1644487-2013-01873
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    A NEUROLOGY OFFICE REPORTED THAT THEY HAD A VNS PATIENT WHOSE DEVICE APPEARS TO BE MOVING AROUND AND IT IS CAUSING THE PATIENT SOME DISCOMFORT. THE PATIENT DENIES ANY MANIPULATION OR TRAUMA AND NOT SURE WHEN THE EVENT BEGAN. THE PATIENT WAS BEING REFERRED FOR A SURGICAL CONSULT AND THERE WILL BE PLANS TO PERFORM A POSSIBLE FULL REVISION. AT THIS TIME THE PATIENT HAS NOT BEEN EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283211 PULSE GEN MODEL 103 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 3245

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other