BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2129986 · Received June 10, 2011

    Report

    Report Number
    1644487-2011-01270
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    September 17, 2010
    Report Date
    May 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A REP THAT THE PT WAS BEING REFERRED FOR ADVERSE EVENTS FOR REVISION SURGERY. THE VNS PT SAID THAT SHE EXPERIENCED SWELLING AND PAINFUL STIMULATION ON HER NECK AT THE ELECTRODE SITE. THE PT WAS SEEN BY HER TREATING SURGEON WHO INDICATED THERE WAS NO SWELLING IN THE NECK AREA BUT INDICATED THERE WAS MUSCLE TWITCHING IN THE PT'S NECK AROUND THE ELECTRODES WITH STIMULATION. THE SURGEON LOWERED PT'S OUTPUT CURRENT TO TOLERABLE LEVELS. MOREOVER, THE PT DENIED ANY TRAUMA TO THE SITE AND WAS REFERRED TO X-RAYS. THE SURGEON FURTHER STATED THAT THE PT COMPLAINED OF ACID REFLUX BUT WAS UNSURE IF THE EVENT WAS RELATED TO VNS OR NOT. ADD'L INFO WAS RECEIVED FROM A COMPANY REP INDICATING SHE WAS PRESENT AT THE PT'S F/U APPOINTMENT ON (B)(6) 2010. THE PT MENTIONED TO THE COMPANY REP THAT SHE WAS IN A CAR WRECK ABOUT A YEAR PRIOR TO VISIT AND THAT'S WHEN THE SYMPTOMS BEGAN. CLINIC NOTES WERE RECEIVED FROM THE COMPANY REP INDICATING "PT PRESENTED FOR TREATMENT ON (B)(6) 2007. SHE WAS EXPERIENCING PAIN WITH DOSING. SHE SUFFERED MVA ON (B)(6) 2009 BUT DOSING REMAINED AT 2 AND INCREASED TO 2.25 AS DEPRESSION WORSENED WITH TREATMENT FOR MS. RECORDS NOTE SUDDEN ONSET OF NECK AND JAW PAIN ON (B)(6) 2010. NO CHANGE IN DOSING. DOSING HAD TO BE DECREASED TO 1 MA TO AMELIORATE THE PAIN." X-RAYS WERE RECEIVED BY THE MFR. NO GROSS FRACTURES OR ACUTE ANGLES WERE VISUALIZED IN THE VISIBLE PORTION OF THE LEAD BODY. HOWEVER, FURTHER INFO INDICATED THAT THE PT WAS BEING REFERRED FOR A FULL REVISION. ALL DIAGNOSTICS ON THE DEVICE WERE SAID TO BE WITHIN NORMAL LIMITS (NO SPECIFICS AVAILABLE), BUT THE PT WAS UNABLE TO TOLERATE PREVIOUS SETTINGS. SINCE THIS WAS OCCURRING, THE PHYSICIAN HAD TO ADD ANOTHER MEDICATION TO HELP THE PT. THE PT UNDERWENT THE FULL REVISION. 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 MUZ CYBERONICS, INC. 102 015227

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention