BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2133616 · Received June 16, 2011

    Report

    Report Number
    1644487-2011-01356
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    January 5, 2011
    Report Date
    May 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS TREATING PHYSICIAN'S NURSE REPORTED THAT THE VNS PT IS SCHEDULED FOR A FULL REVISION SURGERY IN (B)(6) 2011. THE PT HAVE BEEN EXPERIENCING PAIN TO HER NECK UPON STIMULATION SINCE HER BATTERY REPLACEMENT SURGERY IN (B)(6) 2011. THE PT HAS ABOUT 1.3 YEARS LEFT OF BATTERY LIFE AND A LEAD IMPEDANCE VALUE OF 2278 OHMS. THE PT ALSO SAID THAT SHE WAS EXPERIENCING PAIN IN BOTH ARMS SINCE THE BATTERY REPLACEMENT SURGERY IN (B)(6) 2011. THE PHYSICIAN REPORTED THAT THE PT IS AT HIGH SETTINGS BUT THAT DIAGNOSTIC RESULTS ARE WITHIN NORMAL LIMITS. NO CHANGE IN MEDICATION OR SETTINGS AND NO TRAUMA OR MANIPULATION TO THE DEVICE OCCURRED. CLINIC NOTES FROM THE PHYSICIAN WERE REC'D REVIEW OF CLINIC NOTES DATES (B)(6) 2011 REPORT THAT THE PT IS COMPLAINING OF PAIN IN THE CHEST AND LEFT ARM DUE TO VNS. THE CLINIC NOTES ALSO STATE THAT THE PT IS HAVING MORE SEIZURES AND THAT THE VNS MAGNET IS NOT KICKING IN. THE CLINIC NOTES REVEAL THAT THE PT WAS BEING REFERRED TO A VNS IMPLANTING SURGEON FOR A SECOND OPINION REGARDING THE VNS CAUSING CHEST AND LEFT ARM PAIN. ADDITIONAL INFORMATION REGARDING THE PT'S PAIN AND SEIZURES HAS BEEN REQUESTED FROM THE PT'S PHYSICIAN; HOWEVER, NO FURTHER INFORMATION HAS BEEN REC'D TO DATE. WHEN ADDITIONAL INFORMATION IS REC'D, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2839

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention