BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4209421 · Received October 29, 2014

    Report

    Report Number
    1644487-2014-02866
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

    ON (B)(6) 2014 IT WAS REPORTED THAT THE PHYSICIAN WILL NOT PROVIDE ANY FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO SEIZURES. THE PATIENT REPORTED THAT THERE MAGNET SWIPING DID NOT DO ANYTHING FOR HIS SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694190 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3444

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization