BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2860590 · Received December 6, 2012

    Report

    Report Number
    1644487-2012-03223
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    January 21, 2009
    Report Date
    November 6, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS VNS PATIENT'S MOTHER REPORTED THAT THE PATIENT HAD A TOOTH EXTRACTED AS IT HAD DECAYED, AND SHE BEGAN EXPERIENCING SEIZURES WHERE SHE 'MIGRATES' TO WHERE THE TOOTH WAS, AS SHE EXPERIENCES PAIN IN THAT AREA. AFTER THE PATIENT'S REPLACEMENT (DUE TO END OF SERVICE), THE PATIENT EXPERIENCED THIS COMPLICATION IN ADDITION TO SLEEP APNEA AND A HEART MURMUR. IT WAS ALSO STATED THAT THE PATIENT EXPERIENCES A SWELLING ON THE BACK SIDE OF HER HEAD AFTER HER SEIZURES, WHICH HADN'T HAPPENED BEFORE. PROGRAMMING HISTORY IS AVAILABLE FOR (B)(6) 2012. A BATTERY LIFE CALCULATION INDICATED 4.25 YEARS REMAINING ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    FOLLOW-UP ON (B)(6) 2012 SHOWED THAT THE PATIENT WAS SEEN ON (B)(6) 2012. THE SWELLING ON THE BACK OF THE PATIENT'S HEAD WAS AN IRRITATION. THE PATIENT HAD A SEIZURE AT SCHOOL, HIT THE BACK OF HER HEAD, AND THE BACK OF THE HEAD WAS SWOLLEN. THERE WAS NO MENTION OF THE SLEEP APNEA OR ARRHYTHMIA IN THE PATIENT'S CHART; THEREFORE, NO ASSESSMENT REGARDING THESE EVENTS WAS AVAILABLE. THE PATIENT HAD RECENTLY HAD SOME DENTAL WORK, AND THE PHYSICIAN WONDERED IF THE IMPAIRED HEALING OF THE DENTAL WORK WAS RELATED TO THE VNS. THE PATIENT WAS ALSO HAVING SEIZURES AGAIN; HOWEVER, WHEN ASKED, IT WAS STATED THAT THIS WAS NOT AN INCREASE. THE PATIENT'S DEVICE WAS DISABLED, BUT NO CHANGES WERE NOTED, SO THE DEVICE WAS TURNED BACK ON. THE PATIENT WAS NOW ON VIMPAT AND DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200880

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other