BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3010765 · Received March 19, 2013

    Report

    Report Number
    1644487-2013-00732
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 18, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PHYSICIAN DOES NOT BELIEVE THAT THE PAIN THE PATIENT WAS EXPERIENCING WAS RELATED TO VNS THERAPY OR STIMULATION. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. ATTEMPTS TO HAVE THE DEVICE RETURNED TO MANUFACTURER FOR ANALYSIS ARE UNDERWAY; HOWEVER, THE DEVICE HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR AND LEAD. NOTE THAT SINCE A PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL, WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. THERE WAS NO DRIED BODY FLUIDS OR CORROSION IDENTIFIED IN THE LEAD CAVITY OR CONNECTOR BLOCK AREA, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RETURNED ON (B)(6) 2013 AND ARE PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(4) 2013 INDICATE THAT THE PATIENT HAS BEEN EXPERIENCING INTERMITTENT PAIN IN THE LEFT SHOULDER AND NECK REGION AND THAT IT HAS PROGRESSED. IT WAS NOTED THAT THE PAIN IS MORE FREQUENT AND MORE INTENSE AND THAT IT APPEARS TO OCCUR WITH VNS THERAPY STIMULATION. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT NOW INVOLVES THE PATIENT'S LEFT ARM FROM ELBOW TO SHOULDER, THE PATIENT'S LEFT BREAST AND THE LEFT NECK AND EAR REGION. THE NOTES INDICATE THAT X-RAYS OF THE CHEST AND NECK WERE PERFORMED AT THE PATIENT'S LAST VISIT; HOWEVER, NO PROBLEMS WITH THE "PATENCY OF THE DEVICE OR WIRE" WERE NOTED AND IT WAS NOTED THAT THE DISCOMFORT THE PATIENT WAS FEELING WAS DUE TO SCAR TISSUE. IT WAS NOTED THAT THE DEVICE DIAGNOSTICS WERE "NORMAL" AND THAT THE DEVICE WAS PROGRAMMED OFF. THE NOTES INDICATE THAT THE PATIENT RETURNED APPROXIMATELY TWO HOURS LATER WITH A SIGNIFICANT DECREASE IN PAIN. THE PHYSICIAN NOTED THAT THE DEVICE WOULD BE LEFT OFF AND THAT THE PATIENT WOULD BE REFERRED FOR LEAD REPLACEMENT SURGERY AS THE PHYSICIAN NOTED THAT THERE MAY BE A SHORT IN THE WIRE. THE PATIENT HAS BEEN REFERRED FOR SURGERY; HOWEVER, THE SURGERY HAS NOT OCCURRED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114899 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200727

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other