BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3242637 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02216
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 1, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED BOTH THE GENERATOR AND LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(4) 2013, CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED FROM THE REPORTER. THE NOTES DATED (B)(6) 2013 INDICATE THAT THE PATIENT HAD RECEIVED A NECK SOFT TISSUE X-RAY FOR INCREASED NECK PAIN RADIATING FROM THE NECK UP TOWARD THE RETROARTICULAR REGION WITH VNS STIMULATION. THE GENERATOR WAS TURNED OFF FOR SEVERAL MINUTES THEN TURNED ON AGAIN AT A LOWER OUTPUT CURRENT SETTING, WITH THE PROBLEM SEEMINGLY RESOLVED. THE PAIN BEGAN AGAIN (B)(6) 2013, INCREASING IN INTENSITY. IT WAS STATED FROM THE (B)(6) 2013 X-RAYS THAT THE VNS LEAD WAS OBSERVED IN THE LEFT NECK AT THE C6 AND C7-T1 LEVELS AND THAT IT WAS OBSERVED THAT THE VNS GENERATOR WAS OVERLYING THE LEFT CHEST WALL WITH THE LEADS EXTENDING INTO THE BASE OF THE NECK. A SYSTEM DIAGNOSTICS WAS PERFORMED ON (B)(6) 2013, SHOWING THAT ALL WAS ALRIGHT AND THE PHYSICIAN DECREASED THE OUTPUT CURRENT AND ALTERED THE PULSE WIDTH AND SIGNAL FREQUENCY WITHOUT ANY SUCCESS IN THE PATIENT. A REVIEW OF THE MANUFACTURER¿S DEVICE RECORDS WAS PERFORMED FOR THE LEAD AND GENERATOR, CONFIRMING THAT THEY PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. A REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY DETERMINED THAT DATA WAS AVAILABLE FROM (B)(6) 2012, THE DATE OF IMPLANT, TO (B)(6) 2012. NO ANOMALIES WERE SEEN IN THE PROGRAMMING OR DIAGNOSTICS OF THE VNS SYSTEM HISTORY. FOLLOW-UP FROM THE SURGEON DETERMINED THAT THE MECHANICAL COMPLICATION OF THE NERVOUS SYSTEM DEVICE THAT WAS MENTIONED IN THE (B)(6) 2013 NOTES WAS THAT THE STIMULATION OF THE LEADS WAS CAUSING THE PATIENT¿S PAIN. THE SURGEON DOES NOT BELIEVE CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THE PAINFUL STIMULATION AROUND THE PATIENT¿S NECK AND EAR. FURTHER FOLLOW-UP WITH THE OTHER PHYSICIAN DETERMINED THAT THE PATIENT FIRST NOTED THE PAIN AROUND HER NECK AND EAR ON (B)(6) 2013. THE PHYSICIAN ALSO DOES NOT BELIEVE PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED/CONTRIBUTED TO THE PAINFUL STIMULATION AROUND THE NECK AND EAR. THE PHYSICIAN ORIGINALLY BELIEVED THE OUTPUT CURRENT WAS SET TOO HIGH AND WAS CAUSING PAIN, BUT HE STATED THE PAIN AND SYMPTOMS RECURRED EVEN WHEN THE GENERATOR WAS PROGRAMMED OFF. IT HAS BEEN NOTED THAT THE PATIENT IS SCHEDULED FOR LEAD REPLACEMENT SURGERY AND ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN CONTINUATION.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED WHICH INDICATED THAT THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2013 DUE TO PAIN. IT WAS REPORTED THAT THE EXPLANTED DEVICES WERE DISCARDED BY THE EXPLANTING FACILITY AND WILL NOT BE RETURNED TO MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343821 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-30 2937

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention