BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3223767 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02093
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S GENERATOR WAS REPLACED PROPHYLACTICALLY ON (B)(6) 2013. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2013. VISUAL EXAMINATION NOTED TOOL MARKS ON THE PULSE GENERATOR CASE AND HEADER, MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE EXPLANT PROCEDURE. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE INDICATING THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTROCAUTERY TOOL. NO OTHER SURFACE ABNORMALITIES WERE NOTED ON THIS DEVICE. THE SEPTUM WAS NOT CORED. FOR A MAGNET TEST, THE PULSE GENERATOR WAS ATTACHED TO A 4KOHM LOAD AND PROGRAMMED TO ITS ¿AS RECEIVED¿ SETTINGS. A 1.0¿ SPACER BLOCK WAS PLACED ON THE GENERATOR AND A CYBERONICS MAGNET WAS APPLIED. THE GENERATOR OUTPUT WAS INTERRUPTED AND REMAINED INHIBITED AS LONG AS THE MAGNET WAS APPLIED. PROPER MAGNET OUTPUT WAS OBSERVED AFTER THE MAGNET WAS REMOVED. THE MAGNET WAS THEN USED TO INITIATE AN ADDITIONAL STIMULATION BURST (SUCCESSFULLY). THE DEVICE HISTORY SCREEN WAS REVIEWED AND THE TWO MAGNET APPLICATIONS HAD BEEN PROPERLY RECORDED. NO ANOMALIES WERE OBSERVED. PROPER FUNCTIONALITY OF THE PULSE GENERATOR IN ITS ABILITY TO PROVIDE APPROPRIATE PROGRAMMED OUTPUT CURRENTS CAN BE VERIFIED. IN THE LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, SHOWING NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATING THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. 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. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    THE PATIENT WAS HOSPITALIZED DUE TO BREAKTHROUGH SEIZURE ASSOCIATED WITH LOSS OF CONSCIOUSNESS, HEAD INJURY AND BILATERAL EYE ECCHYMOSIS THAT HAPPENED ON (B)(6) 2013. THE SEIZURE WAS NOT WITNESSED AND THEIR TEGRETOL AND DILANTIN LEVELS WERE NORMAL ON ADMISSION. THE PATIENT HAS NOT FURTHER SEIZURES SINCE THAT TIME (CLINIC NOTES WERE DATED (B)(6) 2013). THE PATIENT HAD TOPAMAX ADDED TO HIS EVENING MEDICATIONS FOR BETTER SEIZURE CONTROL. THE PATIENT WAS NOT AT END OF SERVICE AT THE TIME AND DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE PATIENT WAS REFERRED FOR A GENERATOR REPLACEMENT. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323229 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 8861

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R