BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4210557 · Received October 29, 2014

    Report

    Report Number
    1644487-2014-02880
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    January 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT AND/OR PRODUCT PROBLEM; CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED RECLASSIFYING THE EVENT AS AN ADVERSE EVENT AND NOT A PRODUCT PROBLEM. TYPE OF REPORTABLE EVENT; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY REPORTED THE EVENT AS A SERIOUS INJURY INSTEAD OF A DEVICE MALFUNCTION. ADDITIONAL INFORMATION WAS RECEIVED RE-CLASSIFYING THE EVENT AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S DEVICE SETTINGS WERE ADJUSTED. THE INCREASE IN SEIZURES WAS NOT RELATED TO VNS AND ATTRIBUTED TO THE PATIENT¿S STRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES FOR SEVERAL MONTHS. THE PATIENT STATED THAT HE WAS ALSO HAVING PAIN AT HIS LEAD ELECTRODE SITE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692303 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 013834

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention