BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3233794 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02168
    Event Type
    Death
    Date Received
    July 18, 2013
    Date of Event
    June 14, 2010
    Report Date
    June 28, 2013
    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

    ON (B)(6) 2013, GENERATOR AND LEAD PRODUCT WERE RECEIVED FOR THIS PATIENT FROM ANOTHER MEDICAL MANUFACTURER WITH NO INFORMATION PROVIDED. A REVIEW OF THE MANUFACTURER¿S PROGRAMMING HISTORY DATABASE SHOWED THAT DATA WAS ONLY AVAILABLE FROM (B)(6) 2009, THE DATE OF IMPLANT. THERE WERE NO ANOMALIES SEEN IN THE DIAGNOSTICS TESTS PERFORMED THAT DAY. FOLLOW-UP WITH THE PHYSICIAN DETERMINED THAT THE PATIENT WAS DECEASED AT THE AGE OF (B)(6), AND WAS LAST SEEN BY THE PHYSICIAN IN 2009. AN INTERNET SEARCH OF THE PATIENT¿S STATE¿S DEATH RECORDS DETERMINED THAT THE PATIENT DIED (B)(6) 2010. A DEATH CERTIFICATE WAS REQUESTED AND RECEIVED, WHICH STATED THAT THE PATIENT WAS FOUND DEAD ON (B)(6) 2010. THE NOTED CAUSE OF DEATH WAS EPILEPSY WITH ALCOHOLISM LISTED AS A SIGNIFICANT CONTRIBUTING CONDITION. THE PATIENT WAS FOUND IN HIS RESIDENCE AND IT WAS NOTED AS A NATURAL DEATH. THERE WAS NO AUTOPSY PERFORMED AND THE PATIENT WAS CREMATED. A PRODUCT ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTION. A LARGE PORTION OF THE LEAD ASSEMBLY, INCLUDING THE ELECTRODES, WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE RETURNED PORTION OF THE LEAD MEASURED 113MM. THE CONDITION OF THE RETURNED LEAD PORTION WAS 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 PORTION 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 PORTION OF THE DEVICE. PRODUCT ANALYSIS FOR THE GENERATOR IS STILL PENDING.

    Description of Event or Problem · 1

    THE GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS DUE TO PATIENT DEATH. PRODUCT ANALYSIS WAS APPROVED ON (B)(4) 2013. VISUAL EXAMINATION NOTED TOOL MARKS ON THE PULSE GENERATOR CASE AND HEADER. THESE MARKS ARE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE EXPLANT PROCEDURE AS THE MARKINGS ARE CONSISTENT WITH DEVICES TYPICALLY USED IN A SURGICAL PROCEDURE (FORCEPS, ETC). NO OTHER SURFACE ABNORMALITIES WERE NOTED ON THIS DEVICE. THE PULSE GENERATOR CASE HAS WRITING ON THE NO-LOGO SIDE AND THE SEPTUM WAS NOT CORED. IN THE PRODUCT ANALYSIS LABORATORY, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24 HOURS WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. THE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334448 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 201048

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death