BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2862221 · Received December 7, 2012

    Report

    Report Number
    1644487-2012-03242
    Event Type
    Injury
    Date Received
    December 7, 2012
    Date of Event
    August 27, 2012
    Report Date
    November 9, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS REFERRED TO THE SURGEON FOR EXPLANT. SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT WAS EXPERIENCING INCREASED SEIZURES AND INCREASED SEIZURE INTENSITY. THE VNS HAD PREVIOUSLY BEEN PROGRAMMED OFF DUE TO THE PATIENT EXPERIENCING HOARSENESS AND COUGHING, AND WAS CURRENTLY OFF. MANUFACTURER REVIEW OF VNS PROGRAMMING HISTORY DOCUMENTS THE VNS WAS DISABLED ON (B)(6) 2011, AND IT IS UNKNOWN IF THE VNS WAS EVER TURNED BACK ON AFTER THAT DATE. THE PATIENT HAS BEEN REFERRED FOR POSSIBLE VNS GENERATOR REPLACEMENT. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT'S VNS WAS DISABLED DUE TO PSYCHOLOGICAL ISSUES. IT IS UNCLEAR IF THE DEVICE HAS BEEN OFF SINCE (B)(6) 2011, OR WAS TURNED BACK ON AND THEN DISABLED AT A LATER DATE. ALL ATTEMPTS TO THE REPORTER FOR CLARIFICATION AND ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. VNS GENERATOR REPLACEMENT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 201201

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention