BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4103114 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02406
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    November 13, 2013
    Report Date
    August 22, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT WAS BEING REFERRED FOR SURGERY. THE PATIENT WAS EXPERIENCING AT LEAST ONE SEIZURE PER DAY. IT WAS NOTED THAT THE PATIENT¿S DEVICE WAS IMPLANTED FOR SEVEN YEARS WITH A HIGH DUTY CYCLE SO THE PHYSICIAN SUSPECTED THE PATIENT¿S DEVICE HAD LOW BATTERY. AN PATIENT¿S EEG WAS NORMAL. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED NORMAL DIAGNOSTIC RESULTS THROUGH (B)(6) 2011. A BATTERY LIFE CALCULATION USING THE AVAILABLE PROGRAMMING HISTORY SHOWED APPROXIMATELY 1.4 YEARS UNTIL NEOS = YES. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT DUR TO END OF LIFE. THE EXPLANTED GENERATOR WAS RECEIVED FOR ANALYSIS. THE RETURNED PRODUCT FORM INDICATED THAT THE GENERATOR WAS UNABLE TO BE INTERROGATED DUE TO BATTERY DEPLETION. ANALYSIS OF THE GENERATOR WAS COMPLETED ON 10/31/2014. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AS DEFINED IN FINAL ELECTRICAL TESTING. DURING THE PRODUCT ANALYSIS, THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. THE PHYSICIAN REPORTED THAT THE PATIENT IS NONCOMPLIANT WITH MEDICATIONS AND REPORTS INTOLERABLE SIDE EFFECTS FROM MOST ALL MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582695 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014911

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention