BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 3243535 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02229
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    January 1, 2013
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. IN THE PA LAB, 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. OTHER THAN THE OUTPUT BACK-UP CAPACITOR REQUIREMENT, (BACKUP CAPS OUT OF SPECIFICATION, NO PERFORMANCE ISSUE/ACCEPTANCE RANGE CHANGED FROM TIME OF MANUFACTURE), THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF DEATH WAS DETERMINED TO BE A POSSIBLE SUDEP DETERMINED BASED ON THE AVAILABLE INFORMATION AND AN INTERNAL CLASSIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, FOLLOW UP WAS PERFORMED TO FIND OUT WHY THE PATIENT'S EXPLANTED VNS DEVICE WAS RETURNED, AND IT WAS FOUND THAT THE PATIENT PASSED AWAY. THE DATE AND CAUSE OF DEATH WERE UNKNOWN. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL ATTEMPTS FOR INFORMATION HAVE BEEN UNSUCCESSFUL. THE PATIENT'S DEVICE WAS RETURNED ON (B)(6) 2013. PRODUCT ANALYSIS WAS PERFORMED ON THE LEAD, BUT THE GENERATOR IS STILL PENDING ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTIONS NOTE THAT 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 PINS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342415 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death