BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3880754 · Received June 18, 2014

    Report

    Report Number
    1644487-2014-01520
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    January 1, 2009
    Report Date
    May 22, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT WAS HAVING 5-6 SEIZURES PER DAY. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT WAS DOING BETTER FOLLOWING REPLACEMENT SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR WAS DISCARDED AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357675 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 009946

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention