BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3881688 · Received June 18, 2014

    Report

    Report Number
    1644487-2014-01523
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 1, 2014
    Report Date
    January 8, 2018
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT¿S DEVICE WAS MALFUNCTIONING. THE PATIENT STATED THAT HER DEVICE WAS LOSING EFFECTIVENESS. SHE WAS EXPERIENCING AN INCREASE IN SEIZURES THAT WAS BELOW PRE-VNS BASELINE LEVELS. THE PATIENT HAD APPROXIMATELY 50 SEIZURES FROM THE BEGINNING OF MAY TO HER OFFICE VISIT ON (B)(6) 2014. THE NEUROLOGIST RECENTLY INTERROGATED THE PATIENT¿S DEVICE AND NO ISSUES WERE OBSERVED. THE PATIENT WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REPLACEMENT SURGERY. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED TO DATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358100 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201195

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention