BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2981221 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00537
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 29, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALL ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REPORTER INDICATED VIA CLINIC NOTES DATED (B)(6) 2012 RECEIVED TO THE MANUFACTURER THAT A PATIENT WAS EXPERIENCING INCREASED SEIZURES FOLLOWING AN EEG INPATIENT EVALUATION 3 WEEKS PREVIOUSLY. THE PATIENT WAS ALSO NONCOMPLIANT WITH MEDICATION AT THE TIME. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83854 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 015168

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention