BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 302

    MDR report key: 3854239 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01424
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT SURGERY FOR PATIENT COMFORT AND NOT TO PRECLUDE A SERIOUS INJURY. THE PATIENT WAS A NON-RESPONDER TO VNS THERAPY; THEREFORE, THE PATIENT¿S GENERATOR WAS EXPLANTED AND NOT REPLACED. ANALYSIS OF THE RETURNED GENERATOR AND LEAD WAS COMPLETED. MONITORING OF THE GENERATOR 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. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED EXCEPT FOR THE SETSCREW MARKS OBSERVED NEAR THE END OF THE CONNECTOR PIN, INDICATING THE CONNECTOR PIN HAD NOT BEEN FULLY INSERTED INTO THE CAVITY OF THE PULSE GENERATOR AT ONE TIME. THE CONNECTOR PIN WAS INSERTED INTO THE CAVITY OF A TEST GENERATOR TO VERIFY A DIMENSIONAL ISSUE IN THE CONNECTOR PORTION OF THE LEAD WASN¿T PREVENTING THE CONNECTOR PIN FROM BEING FULLY INSERTED INTO A GENERATOR. NO OBSTRUCTIONS WERE NOTED. THE MARKS ARE EVIDENCE OF A POTENTIALLY INSUFFICIENT MECHANICAL CONTACT BETWEEN CONDUCTIVE SURFACES OF THE GENERATOR AND CONNECTOR RING, RESULTING IN A SUSPECT ELECTRICAL CONNECTION TO THE LEAD. HOWEVER, BASED ON THE LOCATION OF THE SETSCREW MARKS ON THE PIN, IT IS UNKNOWN WHETHER A GOOD ELECTRICAL CONNECTION WAS PRESENT FOR THE CONNECTOR RING. CANTED SPRING MARKS WERE NOT OBSERVED ON THE REAR END OF THE SMALL O-RING. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. BASED ON THE FINDINGS, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTIONS OF THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE STATED COMPLAINTS. NOTE THAT SINCE A PORTION OF THE LEAD ASSEMBLY INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS REFERRED FOR SURGERY TO EXPLANT HIS DEVICE DUE TO DISCOMFORT AND PAIN FROM A LEAD PULLING SENSATION WHENEVER HE TURNED HIS HEAD. THE PATIENT¿S DEVICE WAS DISABLED IN 2011 DUE TO LACK OF EFFICACY IN TREATING THE PATIENT¿S DEPRESSION. IT WAS LATER DETERMINED THAT THE PATIENT DID NOT HAVE DEPRESSION BUT WAS SUFFERING FROM AN ANXIETY DISORDER. THE PATIENT¿S GENERATOR AND LEAD WERE EXPLANTED ON (B)(6) 2014. THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332808 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1696

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention