BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2854670 · Received December 3, 2012

    Report

    Report Number
    1644487-2012-03173
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    January 1, 2006
    Report Date
    November 5, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(4), 2012 IT WAS REPORTED THAT THE VNS PATIENT WAS INITIALLY IMPLANTED WITH VNS IN THE (B)(4) 2002 AND BEGAN TO FEEL ILL WITH SIGNIFICANTLY MORE SEIZURES AND ABSENCE SEIZURES IN 2006. THE PATIENT'S CONDITION ALSO WORSENED AND HE BEGAN TO COUGH OFTEN AND LONG AND COUGHED UNTIL HE THREW UP. THE PATIENT WAS REPORTED TO HAVE SEEN THE NEUROLOGIST ON SEVERAL OCCASIONS. IN (B)(4) 2009, THE PATIENT VISITED THE DENTIST AND THE PATIENT'S TEETH WERE GROUND AND AN ULTRASOUND WAS PERFORMED. THE PATIENT 'JUMPED IN THE CHEST' AND WAS HURT BY THE VNS. IT WAS NOTED THAT THIS WAS PAIN AT THE GENERATOR SITE. THE PATIENT HAD SEVERE COUGHING, FELT SICK, AND HAD TROUBLE BREATHING WHEN HE LEFT THE DENTIST'S OFFICE. WHEN THE PATIENT CAME HOME, THE PATIENT'S MOTHER SUSPECTED THAT SOMETHING WAS NOT RIGHT WITH THE VNS. WHEN THE SETTINGS OF THE VNS COULD BE ADJUSTED BY THE HOSPITAL, THE PATIENT COUGHED HARD AND LONG, LOST HER BREATH, AND TURNED BLUE IN THE FACE. IT WAS REPORTED THAT THE PHYSICIAN HAD NOT BEEN THROUGH SOMETHING LIKE THIS BEFORE. IT WAS NOTED THAT THIS EVENT OCCURRED THREE TIMES. IN THE (B)(4) 2010 IT WAS REPORTED THAT THE MANUFACTURER CONCLUDED THAT THE VNS WAS BROKEN IN THE PATIENT'S BODY AND THE PATIENT UNDERWENT REVISION SURGERY FOR A NEW VNS TO BE IMPLANTED. IT WAS REPORTED THAT THE EXPLANTED PRODUCT HAD BEEN PREVIOUSLY BEEN RETURNED FOR PRODUCT ANALYSIS HOWEVER AS THE PRODUCT INFORMATION WAS NOT PROVIDED NOR WAS ADDITIONAL PATIENT IDENTIFYING INFORMATION, THIS COULD NOT BE VERIFIED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other