BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2361527 · Received December 7, 2011

    Report

    Report Number
    1644487-2011-03013
    Event Type
    Injury
    Date Received
    December 7, 2011
    Date of Event
    November 7, 2011
    Report Date
    November 7, 2011
    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
    PHYSICIAN

    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

    REPORTER INDICATED A VNS PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO A POSSIBLE STROKE. THE VNS IS CURRENTLY UNABLE TO BE INTERROGATED AND IS BELIEVED TO BE AT NORMAL END OF SERVICE. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R PULSE GEN MDOEL 102R LYJ CYBERONICS INC 102R 017039

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention