BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4152094 · Received October 8, 2014

    Report

    Report Number
    1644487-2014-02586
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    May 26, 2014
    Report Date
    September 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(4) 2014. NOTE THAT 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 CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. 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, AND NO DISCONTINUITIES WERE IDENTIFIED. ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2014. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT PASSED AWAY ON (B)(6) 2014 DUE TO MIXED DRUG INTOXICATION. THE DECEASED PATIENT WAS FOUND ON HER BED AT HER HOME. THE AUTOPSY REPORT STATED THAT THE MANNER OF DEATH IS ACCIDENT. THERE WAS NO OBVIOUS NOTE OF SUICIDAL IDEATION AT THE SCENE ACCORDING TO NEW YORK STATE POLICE. THE PATIENT¿S SON REPORTED THAT HIS MOTHER HAD "HINTED AT" SUICIDAL IDEATION BUT HAD NO RECENT SUICIDE ATTEMPTS THAT HE WAS AWARE OF. THE PATIENT HAD A HISTORY OF DRUG OVERDOSE IN 2007 AND IT IS UNKNOWN WHETHER THE CIRCUMSTANCES OF THIS OVERDOSE WERE ACCIDENTAL. IN (B)(6) 2013, THE PATIENT¿S MEDICAL RECORDS INDICATE THAT THE PATIENT¿S PRIMARY CARE PHYSICIAN EXPRESSED CONCERN OVER HER USE OF PAIN MEDICATIONS WITH RESULTANT CONFUSION AND SLURRED SPEECH, AND SUBSEQUENTLY REDUCED THE AMOUNT. THE PATIENT¿S GENERATOR AND LEAD WERE EXPLANTED AND RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632596 PULSE GEN MODEL 103 GENERATOR MUZ CYBERONICS, INC. 103 201216

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death