BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2133423 · Received June 15, 2011

    Report

    Report Number
    1644487-2011-01327
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 16, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT HIS LEAD HAD SLIPPED AND IS NOW IN A KNOT. THE PT REPORTED THAT HE IS ABLE TO SEE THE KNOT IN HIS NECK. ALSO, THE PT REPORTED BEING SHOCKED WITH STIMULATION IN THE NECK AND EAR. THE PT SAW HIS PHYSICIAN REGARDING THE ISSUE, AND THE WAS TOLD THE DEVICE "WORKS." THE PT'S SETTINGS WERE REPORTEDLY DECREASED ON (B)(6) 2011 DUE TO THE SHOCKING SENSATION, WHICH HAS HELPED THE ISSUE. HE HAD ALSO BEEN SENT FOR X-RAYS AND A SURGERY CONSULT. FURTHERMORE, THE PT STATED THAT PRIOR TO THE SETTING DECREASE, THE LEFT SIDE OF HIS HEAD HAD BEEN NUMB; HE HAD ALSO BEEN HAVING AN INCREASE IN SEIZURE ACTIVITY. THE MFR'S PROGRAMMING HISTORY WAS SEARCHED AND THE PT'S LAST KNOWN SETTINGS WERE ON (B)(6) 2010. DIAGNOSTIC TESTING ON THIS DATE SHOWED NORMAL DEVICE FUNCTION. LATER INFO WAS REC'D INDICATING NO TRAUMA OR MANIPULATION HAD OCCURRED. RECENT DIAGNOSTICS WERE STATED AS BEING "OK", AND THE PT WAS STILL HAVING LESS SEIZURES THAN BEFORE VNS. NO MEDICATION CHANGES HAD BEEN MADE PRIOR TO THE INCREASE IN SEIZURES. THE SITE ALSO SAID THAT THERE WERE NO MEDICATION CHANGES PRIOR TO THE PAINFUL STIMULATION, BUT THE PT'S PULSE WIDTH AND FREQUENCY WERE DECREASED, AND THE PT THEN COULD TOLERATE STIMULATION. THE PHYSICIAN INDICATED THAT THE NUMBNESS THAT THE PT HAD EXPERIENCED WAS NOT RELATED TO VNS. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 2594

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other