BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2093241 · Received May 3, 2011

    Report

    Report Number
    1644487-2011-00964
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    January 3, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SURGEON THAT A VNS PATIENT'S GENERATOR WAS REPLACED PROPHYLACTICALLY. THE GENERATOR'S OUTPUT WAS PROGRAMMED LOWER PRIOR TO SURGERY TO CONSERVE BATTERY. THE GENERATOR WAS RETURNED TO MFR WHERE PRODUCT ANALYSIS WAS COMPLETED. THE RESULTS OF DIAGNOSTIC TESTING INDICATED THE DEVICE WAS OPERATING PROPERLY. IN THE PA LAB, THE FINAL ELECTRICAL TEST IDENTIFIED OPEN FEED-THRU CAPACITORS. THE OPEN CAPACITORS WERE ISOLATED TO OPEN CONNECTION BETWEEN THE POSITIVE AND NEGATIVE FEED-THRU WIRES AND THE SILVER POLYIMIDE CONNECTION ON THE FEED-THRU CAPACITOR. THE FEED-THRU CAPACITORS PROVIDE EMI PROTECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200778

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR