BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4243940 · Received November 11, 2014

    Report

    Report Number
    1644487-2014-02989
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 13, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGICAL INTERVENTION WAS NOT TAKEN TO PRECLUDE A SERIOUS INJURY. IT IS UNKNOWN IF THE PATIENT'S PAIN WITH DEVICE STIMULATION HAS RESOLVED AS THE PATIENT HAS NOT BEEN SEEN BY THE PHYSICIAN SINCE GENERATOR REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS BEEN SEIZURE FREE FOR THE PAST TWO MONTHS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT BEGAN EXPERIENCING PAINFUL STIMULATION FROM THE GENERATOR SITE UP TO THE NECK AFTER EXPERIENCING A FALL. THE PATIENT WENT TO THE ER ON (B)(6) 2014 DUE TO INTOLERABLE PAIN AND WAS GIVEN PAIN MEDICATION. CLINIC NOTES WERE RECEIVED INDICATING THAT THE PATIENT WAS REFERRED FOR SURGERY ALTHOUGH DIAGNOSTICS SHOWED NORMAL DEVICE FUNCTION AT THE TIME. THE NOTES BRIEFLY MENTION THAT PATIENT¿S PAINFUL STIMULATION. AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726072 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016066

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention