BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2030492 · Received March 9, 2011

    Report

    Report Number
    1644487-2011-00448
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    January 15, 2003
    Report Date
    February 8, 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

    Additional Manufacturer Narrative · 1

    DURING VISUAL ANALYSIS OF THE LEAD, THE LOCATION OF THE SETSCREW MARKS ON THE CONNECTOR PIN AND THE IMPRINT FROM THE CANTED SPRING INDICATED THAT THE LEAD PIN HAD LIKELY NEVER BEEN FULLY INSERTED INSIDE THE GENERATOR.

    Description of Event or Problem · 1

    DURING ANALYSIS OF THE VNS PATIENT'S LEAD AND GENERATOR, IT WAS FOUND THAT PROPER CONNECTION BETWEEN THE LEAD PIN AND THE GENERATOR HAD NOT BEEN ESTABLISHED. SETSCREW MARKS ON THE CONNECTOR PIN AND THE IMPRINT OF THE CANTED SPRING ON THE SMALL O-RING BOOT SUGGEST THAT THE LEAD PIN HAD NOT BEEN FULLY INSERTED DURING THE IMPLANT PROCEDURE. BASED ON THE ANALYSIS OF THE LEAD AND GENERATOR, THERE WERE NO ANOMALIES TO PREVENT THE PROPER INSERTION OF THE CONNECTOR PIN INTO THE GENERATOR. NO PROGRAMMING OR DIAGNOSTICS HISTORY IS AVAILABLE TO CONFIRM IF PROPER CONNECTION HAD EVER BEEN ESTABLISHED. THE REASON FOR THE PATIENT'S VNS EXPLANT WAS DUE TO THE PATIENT NO LONGER HAVING ANY SEIZURES REGARDLESS OF THE VNS BEING ENABLED OR DISABLED. NO OTHER ANOMALIES WERE FOUND WITH THE VNS LEAD OR GENERATOR. NO ADVERSE EVENTS HAVE BEEN REPORTED. ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 7272

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR