BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2974814 · Received February 22, 2013

    Report

    Report Number
    1644487-2013-00486
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    October 1, 2012
    Report Date
    January 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 NOTED THAT THE PATIENT HAD EXPERIENCED AN EXACERBATION IN OVERALL SEIZURE FREQUENCY. THESE NOTES INDICATED THAT THE PATIENT HAD EXPERIENCED SIX GENERALIZED TONIC-CLONIC SEIZURES OVER ONE WEEKEND IN OCTOBER AND THAT SINCE THEN SHE HAS BEEN EXPERIENCING FREQUENT STARING SPELLS. IT WAS ALSO NOTED ON THIS VISIT THAT THE VNS IS SHOWING NEAR END OF SERVICE AND THAT THE PATIENT'S GRANDMOTHER IS INTERESTED IN PURSUING A PROPHYLACTIC BATTERY REPLACEMENT IN THE NEAR FUTURE. ON THE (B)(6) 2012 VISIT, A SMALL ADJUSTMENT TO MEDICATION DOSE WAS MADE. CLINIC NOTES DATED (B)(6) 2012 NOTED THAT THE PATIENT AVERAGED ONE SEIZURE PER WEEK. CLINIC NOTES DATED (B)(6) 2013 INDICATED THAT THE PATIENT WAS EXPERIENCING 2-3 EPISODES OF GENERALIZED TONIC-CLONIC SEIZURES PER WEEK; HOWEVER, IT WAS NOTED THAT SHE HAD CURRENTLY GONE TWO WEEKS WITHOUT ONE. PHYSICIAN INDICATED IN THESE NOTES THAT THE INCREASE IN STARING SPELLS WAS LIKELY RELATED TO THE DECREASE IN VNS BATTERY. MEDICATION CHANGES WERE DEFERRED AT THAT TIME TO PURSUE BATTERY REPLACEMENT. IT WAS NOTED THAT ALTHOUGH THE PATIENT HAD GONE TWO WEEKS WITHOUT A GRAND MAL SEIZURES, THE STARING SPELLS CONTINUED TO BE FREQUENT. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT'S MOTHER FEELS THAT THE VNS THERAPY HAS BEEN HELPFUL AND WILL PURSE BATTERY REPLACEMENT AT THIS TIME. FURTHER FOLLOW-UP REVEALED THAT THE NURSE BELIEVES THE INCREASE IN SEIZURES IS RELATED TO THE DEVICE NEARING END OF SERVICE. THE NURSE ALSO REPORTED THAT IT IS UNKNOWN IF THE INCREASE IN SEIZURES ARE AN INCREASE IN THE PATIENT'S PRE-VNS BASELINE SINCE THE PATIENT HAD BEEN IMPLANTED FOR SO LONG. IT WAS ALSO REPORTED THAT BOTH THE GENERALIZED TONIC-CLONIC SEIZURES AND STARING SPELLS WERE INCREASED. THE NURSE INDICATED THAT THERE WERE NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS THAT PRECEDED THE ONSET OF THE PATIENT'S INCREASE IN SEIZURES. THE PATIENT HAS BEEN REFERRED FOR GENERATOR REPLACEMENT SURGERY; HOWEVER, THE SURGERY HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. THE PULSE GENERATOR WAS RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS ON (B)(4) 2013. THE RETURNED PRODUCT FORM INDICATED THAT THE GENERATOR WAS REPLACED DUE TO ERI = YES. ANALYSIS OF THE GENERATOR IS UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ANALYSIS OF THE PULSE GENERATOR WAS COMPLETED ON (B)(6) 2013. THE PULSE GENERATOR SHOWED AN IFI CONDITION AT 2.674 VOLTS. OTHER THAN THE NOTED CONDITION, 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
    78668 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2495

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other| R