BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2822374 · Received November 7, 2012

    Report

    Report Number
    1644487-2012-02913
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 13, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VOLUNTEER AT A CONFERENCE THAT A VNS PATIENT HAD BEEN GOING INTO STATUS EVERY TIME HIS VNS SETTINGS ARE TURNED UP ( MA ) AND THAT NOW THE DEVICE IS TURNED OFF AS A RESULT. FOLLOW UP WAS MADE THAT THE PATIENT'S REPORTED PHYSICIAN'S OFFICE AND IT WAS REPORTED THAT THEY DID NOT HAVE ANY KNOWLEDGE OF ONE OF THEIR PATIENT'S GOING INTO STATUS WHEN HIS VNS SETTINGS ARE INCREASED. AT THIS TIME NO FURTHER INFORMATION CAN BE ATTAINED UNTIL THE PATIENT REPORTS THE EVENT TO THEIR FOLLOWING PHYSICIAN. IF FURTHER INFORMATION IS ATTAINED AT A LATER DATE WITH THE PATIENT IDENTITY FURTHER INVESTIGATION WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK PULSE GEN MODEL UNK LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention