BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2874127 · Received December 14, 2012

    Report

    Report Number
    1644487-2012-03356
    Event Type
    Death
    Date Received
    December 14, 2012
    Date of Event
    September 27, 2012
    Report Date
    November 15, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE DATE OF DEATH WAS (B)(6) 2012. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS AND ANALYSIS HAS SINCE BEEN COMPLETED. DURING PRODUCT ANALYSIS OF THE GENERATOR, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. 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. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTION. NOTE THAT A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; 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. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN 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. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CORONER WHO INDICATED THAT AN AUTOPSY WAS PERFORMED ON THE PATIENT. THE CORONER RULED THE PATIENT'S DEATH TO BE SUDEP. THE CORONER DID NOT BELIEVE THAT THE SUDEP WAS RELATED TO VNS. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE TREATING PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PATIENT'S LAST KNOWN PHYSICIAN INDICATED THAT THE LAST TIME SHE WAS SEEN WAS IN (B)(6) 2011. AT THAT POINT, WE REFERRED HER FOR A BATTERY REPLACEMENT; HOWEVER HER GENERATOR WAS STILL FUNCTIONING. AS THEY HAD NOT SEEN THE PATIENT SINCE 2011, THEY WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 011989

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death