BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2389370 · Received December 27, 2011

    Report

    Report Number
    1644487-2011-03203
    Event Type
    Malfunction
    Date Received
    December 27, 2011
    Date of Event
    November 27, 2011
    Report Date
    December 1, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO NON-CONFORMANCE OR OTHER ADVERSE CONDITIONS WITH THE GENERATOR PRIOR TO SHIPMENT. BRAND NAME, CORRECTED DATA: INITIAL REPORT INDICATED THE LEAD WAS THE SUSPECT DEVICE HOWEVER NEW INFORMATION RECEIVED INDICATES THE ISSUE WAS MOST LIKELY CAUSED BY THE DETACHMENT OF THE GENERATOR HEADER. TYPE OF DEVICE, NAME, CORRECTED DATA: INITIAL REPORT INDICATED THE LEAD WAS THE SUSPECT DEVICE HOWEVER NEW INFORMATION RECEIVED INDICATES THE ISSUE WAS MOST LIKELY CAUSED BY THE DETACHMENT OF THE GENERATOR HEADER. MODEL #, SERIAL #, LOT#, EXPIRATION DATE, CORRECTED DATA: INITIAL REPORT INDICATED THE LEAD WAS THE SUSPECT DEVICE THEREFORE THE LEAD MODEL NUMBER, SERIAL NUMBER, LOT NUMBER, AND EXPIRATION DATE WERE PROVIDED HOWEVER NEW INFORMATION RECEIVED INDICATES THE ISSUE WAS MOST LIKELY CAUSED BY THE DETACHMENT OF THE GENERATOR HEADER. MANUFACTURER DATE, CORRECTED DATA: INITIAL REPORT INDICATED THE LEAD WAS THE SUSPECT DEVICE THEREFORE THE LEAD MANUFACTURER DATE WAS PROVIDED HOWEVER NEW INFORMATION RECEIVED INDICATES THE ISSUE WAS MOST LIKELY CAUSED BY THE DETACHMENT OF THE GENERATOR HEADER.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2011 THAT A VNS PATIENT WALKED INTO A DOOR AND THE EDGE OF THE DOOR HIT THE PATIENT IN THE CHEST CLOSE TO THE GENERATOR SITE. IMMEDIATELY FOLLOWING THE HIT, THE PATIENT BEGAN TO FEEL STIMULATION MORE INTENSELY IN HIS NECK AND CONTINUED TO FEEL THE STIMULATION HOWEVER THE INTENSITY LESSENED OVER TIME. SYSTEMS DIAGNOSTICS WERE PERFORMED WHICH RESULTED IN OK/OK/1/NO BUT NORMAL MODE DIAGNOSTICS RESULTED IN 7/LIMIT/HIGH. THE DEVICE WAS PROGRAMMED OFF AND THE PATIENT WAS REFERRED FOR X-RAYS. THE PATIENT'S OUTPUT CURRENT IS 2.75 MA. ON (B)(6) 2011, SYSTEMS AND NORMAL MODE DIAGNOSTICS WERE REPEATED WHICH RESULTED IN 7/LIMIT/HIGH/NO. THE PATIENT WAS SCHEDULED FOR A SURGICAL CONSULT AND X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW. A REVIEW OF THE X-RAYS DID NOT SHOW ANY ANOMALIES HOWEVER IT WAS NOTED THAT IN A CERTAIN PORTION OF THE LEAD, THE LEAD WAS TWISTED ONTO ITSELF SUGGESTING SOME SORT OF PATIENT MANIPULATION OR TRAUMA. CLINIC NOTES WERE RECEIVED DATED (B)(6) 2011 WHERE THE DEVICE WAS FOUND TO BE PROGRAMMED TO 2.75/30/500/30/3/3/500/30. SYSTEMS DIAGNOSTICS RESULTED IN OK/OK/1/NO AND NORMAL MODE DIAGNOSTICS RESULTED IN 7/LIMIT/HIGH/NO. THE DEVICE WAS PROGRAMMED TO 0 MA DUE TO THE HIGH LEAD IMPEDANCE AND THE PATIENT'S AEDS WERE ADJUSTED TO COMPENSATE FOR THE PATIENT NOT RECEIVING VNS THERAPY. THE NOTES INDICATE THAT FOLLOWING THE TRAUMA TO THE GENERATOR SITE, THE PATIENT FELT DISCOMFORT IN THE THROAT WITH DEVICE STIMULATION. HE ALSO HAS AN INCREASE IN HIS COUGH REFLEX. THE PATIENT HAD REPORTEDLY TOLERATED HIS SETTINGS UNTIL THE TRAUMA TO THE GENERATOR SITE AND USING THE MAGNET TO TEMPORARILY DISABLE THE DEVICE DID NOT HELP. THE DISCOMFORT OCCURRED FOR 24 TO 36 HOURS BUT HAS SLIGHTLY LESSENED IN INTENSITY. IF THE PATIENT WAS SETTING UP AND LEANING FORWARD, THE DISCOMFORT WAS NOT AS BAD. THE PATIENT WEIGHS (B)(6). GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REVEALED THAT DURING REVISION SURGERY, THE GENERATOR SITE WAS OPENED AND THE HEADER OF THE GENERATOR HAD SEPARATED FROM THE CAN. THE LEAD ITSELF APPEARED TO BE INTACT. WITH THE GENERATOR HEADER SEPARATION, LEAD IMPEDANCE COULD NOT BE ASSESSED SO A FULL REVISION WAS PERFORMED WHERE THE LEAD AND GENERATOR WERE EXPLANTED AND REPLACED. THE EXPLANTED PRODUCTS HAVE BEEN RETURNED TO THE MANUFACTURER AND PRODUCT ANALYSIS IS CURRENTLY BEING PERFORMED. THE DHR FOR THE GENERATOR WAS REVIEWED AND NO NON-CONFORMANCES OR OTHER ADVERSE CONDITIONS WERE NOTED IN THE GENERATOR'S DHR.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE EXPLANTED LEAD AND GENERATOR HAS BEEN COMPLETED. NOTE THAT A LARGE PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE SECTION WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. 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 PINS 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. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTIONS OF THE DEVICE. THE SEPTA OF THE EXPLANTED GENERATOR WERE NOT CORED, THUS ELIMINATING THE POSSIBILITY OF A POTENTIAL UNINTENDED ELECTRICAL CURRENT PATH THROUGH BODY FLUIDS, (ADDRESSING THE ALLEGATIONS OF "PAINFUL STIMULATION" AND "STIMULATION TO UNINTENDED SITE"). A WINDOW WAS CUT INTO THE PULSE GENERATOR CASE TO ACCESS THE FEED-THRU OUTPUT CONNECTIONS ON THE SUBSTRATE. BENCH TEST CONNECTORS WERE ATTACHED TO THE NEGATIVE AND POSITIVE FEED-THRU WIRES, AT THE SUBSTRATE, TO PERFORM A FINAL ELECTRICAL TEST. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. IT IS VERY LIKELY THAT THE IDENTIFIED, "DETACHMENT OF COMPONENT(S) HEADER", OCCURRED WHILE THE GENERATOR WAS IMPLANTED, AND IS RELATED TO PATIENT TRAUMA. OTHER THAN THE HEADER OBSERVATION, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 200843

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR