BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2220191 · Received August 9, 2011

    Report

    Report Number
    1644487-2011-01811
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY DID NOT INCLUDE THE PRODUCT CODE.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PATIENT'S TREATING NEUROLOGIST INDICATED THAT ALL OF THE PATIENT'S REPORTED SYMPTOMS WERE NOT RELATED TO VNS. THE DEVICE WAS EXPLANTED FOR PATIENT COMFORT. THE NEUROLOGIST INDICATED THAT WITH VNS, THE PATIENT'S SEIZURES WERE WELL CONTROLLED. NOW, WITH THE DEVICE EXPLANTED, THE PATIENT IS STILL HAVING SEIZURES. THE REPORTED DYSPHASIA, FLUSHING AND DIZZINESS WERE NOT OCCURRING WITH STIMULATION, AND THE PATIENT HAS A MEDICAL HISTORY OF DYSPHASIA, FLUSHING, AND PSYCHOSIS PRE-VNS. NO DIAGNOSTICS WERE PERFORMED, ALTHOUGH THE DEVICE WAS SAID TO BE PROGRAMMED ON. THE NEUROLOGIST ALSO INDICATED THAT THE PATIENT'S SYMPTOMS HAVE NOT IMPROVED SINCE THE EXPLANT, AS IT WAS AGAIN REITERATED THAT THE PATIENT'S SYMPTOMS WERE NOT RELATED TO VNS,

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS AGAIN HOSPITALIZED. THE PATIENT WAS EXPERIENCING A FEVER, TROUBLE SWALLOWING, DIZZINESS, REDNESS AND HEATING AROUND HER DEVICE, AND SWELLING OF HER LEFT LYMPH NODES. THE PATIENT INDICATED THAT SHE WOULD BE FOLLOWING UP WITH A SURGEON TO HAVE THE VNS EXPLANTED. THE PATIENT BELIEVES THAT THIS IS ALL RELATED TO AN AUTO-IMMUNE RESPONSE CAUSED BY THE IMPLANTED DEVICE. THE PATIENT'S VNS DEVICES WERE EXPLANTED ON (B)(6) 2011. THE DEVICES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PT HAD BEEN HOSPITALIZED DUE TO A POSSIBLE AUTO-IMMUNE RESPONSE TO VNS. ADD'L INFO WAS RECEIVED INDICATING THAT THE PT HAS A MEDICAL HISTORY PRE-VNS OF AUTO-IMMUNE DISEASE. THE EXACT RESPONSE TYPE IS UNK; HOWEVER, IT WAS RELATED TO THE PT'S NODULES. THE NEUROLOGIST DOES NOT FEEL THAT THE RESPONSE WAS RELATED TO VNS, HOWEVER, AS THE PT RECENTLY UNDERWENT VNS SURGERY, THIS CANNOT BE RULED OUT. NO ADD'L INFO IS AVAILABLE TO DATE.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER ON (B)(6) 2011. PRODUCT ANALYSIS WAS COMPLETED FOR THE RETURNED GENERATOR. RESULTS OF DIAGNOSTIC TESTING AND MONITORING INDICATED THE DEVICE WAS OPERATING PROPERLY. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. VISUAL INSPECTION RESULTS REVEALED NO EXTERNAL DEVICE ABNORMALITIES. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. PRODUCT ANALYSIS ON THE LEAD WAS ALSO COMPLETED. NOTE THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE RESISTANCE MEASUREMENTS TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PIN AT ONE POINT IN TIME. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO DISCONTINUITIES WERE IDENTIFIED. A SLICE MARK WAS OBSERVED ON THE OUTER SILICONE TUBING. THE MARK PENETRATED THE INSULATION AND APPEARED TO HAVE BEEN MADE BY A SHARP OBJECT WHICH COULD HAVE OCCURRED DURING THE EXPLANT PROCEDURE, HOWEVER THIS CANNOT BE CONFIRMED. THE INNER SILICONE TUBES DID NOT APPEAR TO BE DAMAGED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTION OF THE DEVICE. NOTE THAT SINCE THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. ADDITIONAL INFORMATION WAS ALSO RECEIVED ON THE RETURN PRODUCT FORM FOR THE RETURNED PRODUCTS. IT WAS INDICATED THAT THE LEAD AND GENERATOR WERE EXPLANTED FOR ADVERSE EVENTS SUCH AS PSYCHOSIS, ANXIETY, AND THE AUTO-IMMUNE DEFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 NONE LYJ CYBERONICS, INC. 103 2905

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention