BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3926427 · Received July 10, 2014

    Report

    Report Number
    1644487-2014-01747
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    January 20, 2013
    Report Date
    June 16, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT SURGERY ON (B)(6) 2013 TO EXPLANT THE GENERATOR AND LEAD DUE TO END OF SERVICE. THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED GENERATOR SHOWED A NON-IFI CONDITION. MONITORING OF THE DEVICE OUTPUT SIGNAL SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE LEAD ASSEMBLY HAS DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE BILUMEN TUBING. THE SETSCREW MARKS FOUND ON THE CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED. BASED ON THE FINDINGS, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTION OF THE DEVICE. NOTE THAT SINCE THE ELECTRODE ARRAY WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. FOLLOW-UP REVEALED THAT THE PATIENT¿S GENERATOR AND LEAD WERE EXPLANTED DUE TO A DEEP-SEATED INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE PATIENT HAS NOT BEEN RE-IMPLANTED TO DATE. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404527 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2918

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention