BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3812438 · Received May 15, 2014

    Report

    Report Number
    1644487-2014-01272
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 21, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE INCORRECT AGE. DATE OF EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE INCORRECT DATE.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED VNS PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2014 DUE TO A SEIZURE. THE PATIENT HAD A FEVER AND WAS ADMITTED TO THE HOSPITAL THAT DAY FOR A POSSIBLE INFECTION AT HER INCISION SITE. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. THE PATIENT¿S DEVICE WAS TESTED AT THE HOSPITAL AND REPORTED TO BE FUNCTIONALLY NORMALLY. THE NEUROLOGIST STATED THAT THE PATIENT¿S SEIZURE WAS DUE TO HER DEVICE BEING PROGRAMMED TO A LOW OUTPUT CURRENT (0.25MA). THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014 TO EXPLANT HER GENERATOR AND LEAD DUE TO INFECTION. WOUND CULTURES FROM THE PATIENT¿S LEAD INCISION SITE WERE TAKEN BUT THE RESULTS HAVE NOT BEEN PROVIDED. THE EXPLANTING FACILITY DISCARDED THE EXPLANTED DEVICES; THEREFORE, NO ANALYSIS CAN BE PERFORMED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RE-IMPLANTED WITH VNS ON (B)(6) 2015. DUE TO INFECTION SURROUNDING THE LEFT VAGAL NERVE PREVIOUSLY, THE SURGEON ELECTED TO IMPLANT ON THE RIGHT VAGUS NERVE BASED ON HIS MEDICAL JUDGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291806 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3790

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention