BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2810231 · Received October 31, 2012

    Report

    Report Number
    1644487-2012-02809
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S INCREASED SEIZURES AND NECK MUSCLE SPASMS WERE FELT TO BE DUE TO THE VNS. THE PATIENT DOES PARTICIPATE IN WEIGHT LIFTING ACTIVITIES WHICH MAY HAVE PRECIPITATED THE INCREASED SEIZURES AND NECK MUSCLE SPASMS. THE NECK MUSCLE SPASMS WERE OCCURRING WITH VNS STIMULATION. THE PATIENT DID NOT HAVE A PRE-VNS HISTORY OF NECK MUSCLE SPASMS.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT WAS SEEN IN THE EMERGENCY ROOM ON (B)(6) 2012, DUE TO INCREASED SEIZURES AND A "CLICKING" SOUND IN THE PATIENT'S CHEST. THE PATIENT'S NECK WAS ALSO SEEN TO TWITCH WITH EACH CLICKING SOUND APPROXIMATELY EVERY 10 SECONDS. IT WAS SUSPECTED THERE MAY BE A MALFUNCTION WITH THE PATENT'S VNS DEVICE DUE TO THE CLICKING SOUND. THE PATIENT WAS ALSO EXPERIENCING MILD BRADYCARDIA (REPORTED VIA MDR #1644487-2012-02749), BUT WAS STABLE AT THE MOMENT. NO MEDICATION CHANGES OCCURRED PRIOR TO THE EVENTS. THE PATIENT HAD NO TRAUMA AND DID NOT MANIPULATE THE VNS. THE VNS GENERATOR HAS NO AUDIBLE COMPONENTS, AND IS INCAPABLE OF MAKING ANY NOISE. THE PATIENT WAS NOT FEELING WELL WHILE HE WAS AT WORK, AND IT IS BELIEVED FATIGUE MAY HAVE CONTRIBUTED TO THE SEIZURE INCREASE. THE PATIENT LATER HAD THE VNS GENERATOR AND LEAD REPLACED DUE TO AN UNKNOWN REASON ON (B)(6) 2012. THE EXPLANTED DEVICES WILL NOT BE RETURNED DUE TO THE HOSPITAL'S POLICY. A VNS BATTERY LIFE ESTIMATE PERFORMED BY THE MANUFACTURER YIELDED APPROXIMATELY 0.75 YEARS REMAINING. ALL ATTEMPTS TO THE TREATING NEUROLOGIST FOR FURTHER INFORMATION REGARDING THE EVENTS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 200828

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention