BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2821305 · Received November 6, 2012

    Report

    Report Number
    1644487-2012-02905
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 20, 2009
    Report Date
    October 10, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTER INDICATED VIA CLINIC NOTES RECEIVED TO THE MANUFACTURER DATED (B)(6) 2009 THAT A VNS PATIENT HAD EXPERIENCED INCREASED SEIZURE FREQUENCY IN THE PREVIOUS MONTH. THE VNS "OFF" TIME WAS INCREASED FROM 5 MINUTES TO 3 MINUTES. (B)(4) MEDICATION WAS ALSO INCREASED. ALL ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 014714

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention