BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3870128 · Received June 12, 2014

    Report

    Report Number
    1644487-2014-01490
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS NOT CERTAIN THAT THE PATIENT'S DEVICE WAS WORKING. THE PHYSICIAN'S OFFICE REPORTED THAT THE VNS IS NOT WORKING AND IS NOT SURE WHY THE PHYSICIAN THOUGHT THIS. THE PATIENT WAS REFERRED TO SURGEON. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. IN THE PA 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. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR REPLACEMENT. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. THE IMPLANT CARD WAS RECEIVED AND STATED THE REASON FOR REPLACEMENT WAS BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348861 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 009637

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR