BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 4120152 · Received September 25, 2014

    Report

    Report Number
    1644487-2014-02485
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    May 1, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT VNS PATIENT BEGAN EXPERIENCING AN INCREASE IN SEIZURES ABOVE PRE-VNS BASELINE LEVELS IN (B)(6) 2014. THE INCREASE IN SEIZURES WAS REPORTEDLY DUE TO A DECREASE IN BATTERY LIFE OF THE PATIENT¿S DEVICE. THERE WERE NO EXTERNAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION. ANALYSIS OF THE RETURNED GENERATOR WAS COMPLETED. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE BATTERY SHOWED A IFI=NO CONDITION. MONITORING OF THE DEVICE 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2014 INDICATED THAT THE PATIENT HAD BEEN EXPERIENCING FLURRIES OF SEIZURES, WITH THE LAST OCCURRING ON (B)(6) 2014. SHE HAD BEEN TREATED TWICE AT THE EMERGENCY ROOM THE SEIZURES. THE PATIENT WAS GIVEN LORAZEPAM, WHICH WAS THEN TAPERED OFF APPROXIMATELY 2 WEEKS LATER, AND ON THE LAST DAY OF TAPERING OFF THE PATIENT HAD 10-15 SECOND LASTING GENERALIZED TONIC SEIZURE ACTIVITY ABOUT EVERY 2 MINUTES WITHOUT REGAINING HER BASELINE MENTAL STATUS. SHE THEN HAD LONGER-LASTING GENERALIZED TONIC-CLONIC SEIZURE LASTING UP TO ONE MINUTE. IT WAS REPORTED BY THE CARETAKER THAT ONCE THE PATIENT RECEIVES LORAZEPAM FOR THE FLURRIES OF SEIZURES SHE DOES NOT HAVE ANY SEIZURES FOR A COUPLE OF DAYS AFTER. THE VNS WAS PROGRAMMED TO 1.25 MA FROM 1.0 MA. THE PHYSICIAN COMMENTED THAT THE PATIENT'S SEIZURES HAVE RECENTLY WORSENED. CLINIC NOTES DATED (B)(6) 2014 INDICATED THAT PATIENT CONTINUED TO HAVE FLURRIES OF SHORT LASTING SEIZURES THAT ARE USUALLY LASTING FOR A FEW SECONDS TO SEVERAL SECONDS AT A TIEM. ON OCCASION, SHE IS NOT ABLE TO RETURN TO HER BASELINE MENTAL STATUS. AN AMBULANCE WAS CALLED ON ONE OCCASION WHEN SHE DID NOT RETURN TO BASELINE MENTAL STATUS FOR ABOUT A HALF HOUR; HOWEVER, THE HAD RETURNED TO IT BY THE TIME THEY ARRIVED. THE PATIENT RECEIVED EXTRA DOSES OF LORAZEPAM PER SEIZURE PROTOCOL FOR THE FLURRIES OF SEIZURES. CLINIC NOTES DATED (B)(6) 2014 INDICATED THAT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (B)(6) 2014 FOR FLURRIES OF SEIZURES, WAS DIAGNOSED WITH UTI AND GIVEN T SEPTRA DS. THE PHYSICIAN REVIEWED THE SEIZURE DIARY WHICH SHOWED SHE HAD SHORT LASTING SEIZURES (3-5 SECONDS) ALMOST DAILY WITH FLURRIES ABOUT ONCE A WEEK. ON (B)(6) 2014 AFTER EYE DILATION FOR OPTOMETRIC EXAM SHE HAD A TOTAL FO 37 SHORT SEIZURE ACTIVITIES WITHOUT REDUCTION IN HER MENTAL STATUS. SHE WAS RECEIVING LORAZEPAM FOR TREATMENT OF SEIZURES PER PROTOCOL. THE VNS WAS PROGRAMRED TO 1.75 MA. THE NOTES INDICATED THAT THE PATIENT HAS BEEN HAVING INCREASING FLURRIES OF SHORT SEIZURES. IT WAS NOTED THAT THE VNS BATTERY IS STARTING TO DECLINE AND THE PATIENT REQUIRED FREQUENT MONITORING OF THE VNS. IF THE PATIENT'S SEIZURES CONTINUE OR WORSEN, THE PATIENT WILL BE REFERRED FOR BATTERY REPLACEMENT SOONER RATHER THAN LATER. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT. NO KNOWN SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014. PRE-OPERATIVE SYSTEM DIAGNOSTICS SHOWED NORMAL DEVICE FUNCTION. WHILE THE SURGEON NOTED THAT THERE WAS A SIGNIFICANT AMOUNT OF BATTERY LIFE REMAINING AND NORMAL DEVICE FUNCTION, THE NEUROLOGIST ELECTED TO CONTINUE WITH GENERATOR REPLACEMENT. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599030 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202091

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention