BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 5058061 · Received September 4, 2015

    Report

    Report Number
    1644487-2015-05708
    Event Type
    Injury
    Date Received
    September 4, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 6, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    GENERATOR REPLACEMENT SURGERY OCCURRED ON (B)(6) 2015. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED TO-DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO-DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR MOVES AROUND HER CHEST WALL AND THAT IT WOULD BE ADDRESSED WITH AN UPCOMING GENERATOR REPLACEMENT SURGERY REPORTED TO BE DUE TO END-OF-SERVICE. IT WAS REPORTED THAT THE GENERATOR WAS UNABLE TO BE INTERROGATED DUE TO SUSPECTED END OF SERVICE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE NOT BEEN SUCCESSFUL TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588960 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 8350

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention