BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 7351364 · Received March 19, 2018

    Report

    Report Number
    1644487-2018-00427
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    December 13, 2017
    Report Date
    June 9, 2026
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT THE PATIENT HAS SIGNIFICANT HOARSENESS WITH VNS INITIALLY. THE PATIENT WAS SLOWLY TITRATED UP, BUT WAS STILL HAVING GRATER VOICE ISSUES AND THEIR VOICE WAS GONE FOR A WHILE. IT WAS LATER REPORTED THAT THE PATIENT WASN'T ABLE TO TALK FOLLOWING SURGERY WHICH CAUSED THE MEDICAL PROFESSIONAL TO ATTRIBUTE THE VOCAL CORD PARALYSIS TO THE VNS SURGERY. THE PATIENT BEGAN TITRATION A WEEK LATER DESPITE NO IMPROVEMENT IN THEIR VOICE. DURING THE FOLLOWING TITRATION VISIT, THE PATIENT'S VOICE HAD RETURNED TO HALF VOLUME AND STAYED AT THIS LEVEL. IN A FOLLOWING VISIT, THE PATIENT'S DEVICE WAS PROGRAMMED OFF TO ALLOW THE VOCAL CORD TO REST. THE PATIENT¿S DEVICE WAS RE-ENABLED AT A LOWER CURRENT DUE TO THE PATIENT HAVING ADDITIONAL SEIZURES AFTER DISABLEMENT. THE MEDICAL PROFESSIONAL ALSO STATED THAT THE PATIENT HAD A LUNG INFECTION AND OTHER ISSUES UNRELATED TO THE VNS DEVICE WHICH COULD HAVE CONTRIBUTED TO THE VOCAL CORD ISSUES. THE PATIENT WAS SEEN BY AN ENT FOR THE VOICE ISSUES. THE ENT FOUND THE PATIENT HAD LEFT VOCAL CORD PARALYSIS. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191505 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 204171 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other