BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4090296 · Received September 15, 2014

    Report

    Report Number
    1644487-2014-02341
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    June 24, 2014
    Report Date
    August 18, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR AND LEAD EXPLANT DUE TO INFECTION. THE PATIENT HAD RECENTLY BEEN IMPLANTED WITH VNS. THE EXPLANTED GENERATOR AND LEAD WERE RETURNED FOR ANALYSIS. ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(6) 2014. THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED. ANALYSIS OF THE GENERATOR IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON 09/24/2014. ELECTRICAL TEST SHOWED THAT THE PULSE GENERATOR WAS OPERATING WITHIN SPECIFICATION. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568721 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202928

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention