BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2241035 · Received August 10, 2011

    Report

    Report Number
    1644487-2011-01824
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    September 1, 2009
    Report Date
    July 11, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN IMPLANTING HOSPITAL REPORTED THAT THE VNS PT'S DEVICE WAS DISABLED SINCE (B)(6) 2009 DUE TO DYSPNEA AND THE PT HAD THEIR DEVICE EXPLANTED ON (B)(6) 2011. THE EXPLANTED PRODUCT WAS RETURNED TO THE MFR FOR PRODUCT ANALYSIS WHICH COMPLETED ON (B)(6) 2011. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVAL SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECS AND THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE PT HAD BEEN PREVIOUSLY REPORTED TO THE MFR THAT THE GENERATOR HAD BEEN DISABLED ON (B)(6) 2009 BECAUSE THE PT FELT THAT THE DEVICE WAS CONTINUOUSLY STIMULATING HIM AND GAVE HIM TEMPORARY VOCAL CORD PARALYSIS. THE PT DID NOT REPORT ANY PROBLEMS WITH DYSPNEA AT THAT TIME. GOOD FAITH ATTEMPTS FOR ADD'L INFO FROM THE SURGEON HAVE BEEN TO NO AVAIL THUS FAR. A USER FACILITY MEDWATCH WAS RECEIVED (B)(4) BY THE MFR ON (B)(6) 2011 WHICH REVEALED THAT THE PT HAS BEEN EXPERIENCING DYSPNEA WHILE RUNNING WHICH EVENTUALLY DEVELOPED INTO SEVERE SHORTNESS OF BREATH. THE VNS WAS ALSO CAUSING CONSTRICTION OF THE VOCAL CORDS. HIS VNS WAS DISABLED AND HAS BEEN OFF SINCE. THE PT THEN HAD THE VNS GENERATOR REMOVED. WHEN ADD'L INFO HAS BEEN RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 016869

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention