BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4163655 · Received October 10, 2014

    Report

    Report Number
    1644487-2014-02632
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 30, 2014
    Report Date
    September 11, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INDICATED THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES AND A GRAND MAL SEIZURES; HOWEVER, THERE IS NO INDICATION THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES AND THE GRAND MAL SEIZURE WAS NOT A NEW SEIZURE TYPE. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. MAGNET ACTIVATIONS PERFORMED DURING OUTPUT MONITORING (AT A DISTANCE OF ONE-INCH, SPACER BLOCK, FROM THE GENERATOR), DEMONSTRATE THE APPROPRIATE MAGNET OUTPUT FOR THE PROGRAMMED SETTINGS. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY VOLTAGE SHOWED AN NEOS=YES CONDITION.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO A NEAR END OF SERVICE CONDITION. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 NOTE THAT THE PATIENT EXPERIENCED SIX SEIZURES IN A TWO WEEK PERIOD ONE OF WHICH WAS A GRAND MAL SEIZURE. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING A LOT OF AGGRESSION. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO KNOWN SURGICAL INTERVENTIONS HAVE BEEN PERFORMED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639284 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 202060

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention