BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4123272 · Received September 26, 2014

    Report

    Report Number
    1644487-2014-02496
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    January 1, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT¿S SLEEP APNEA AND FATIGUE OCCURRED ONE WEEK FOLLOWING IMPLANT SURGERY. RESULTS OF THE SLEEP STUDY SHOWED THESE ISSUES OCCURRED WITH DEVICE STIMULATION ON-TIMES AND RESOLVED WHEN THE DEVICE WAS DISABLED. THE PATIENT¿S DEVICE SETTINGS WERE SUBSEQUENTLY REDUCED.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED GENERATOR WAS COMPLETED. THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 BECAUSE HIS DEVICE WAS NO LONGER CONTROLLING HIS SEIZURES AS EFFECTIVELY AS BEFORE. THE PATIENT HAD BEEN EXPERIENCING AN INCREASE IN SEIZURES AND HIS DEVICE WAS REPORTEDLY NOT AT END OF SERVICE. SINCE BEING IMPLANTED WITH VNS, THE PATIENT WAS NO LONGER HAVING GTC SEIZURES AND ONLY EXPERIENCED ABSENCE SEIZURES. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY. FOLLOW-UP REVEALED THAT THE PATIENT WAS LETHARGIC AND FATIGUED. THE PATIENT WAS SENT FOR A SLEEP STUDY AS HE MAY HAVE DEVELOPED SLEEP APNEA. THESE SYMPTOMS WERE NOT PRESENT PRIOR TO REPLACEMENT SURGERY. THE PHYSICIAN STATED THAT THE SYMPTOMS WERE NOT DUE TO POST-SURGICAL RECOVERY BUT MAY BE DUE TO THE QUICK RAMP UP TO PREVIOUS DEVICE SETTINGS. NO MEDICATIONS CHANGES WERE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602830 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 017246

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention