BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6437699 · Received March 27, 2017

    Report

    Report Number
    1644487-2017-03487
    Event Type
    Death
    Date Received
    March 27, 2017
    Date of Event
    July 18, 2016
    Report Date
    May 8, 2017
    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

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION?, CORRECTED DATA: YES. IF YES, RETURNED TO MANUFACTURER ON (MO/DAY/YR): 03/24/2017. INITIAL MDR INADVERTENTLY PROVIDED INCORRECT INFORMATION THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    THE MEDICAL EXAMINER'S OFFICE CALLED TO ASK ABOUT RETURNING THE EXPLANTED DEVICE OF THE DECEASED PATIENT. THE CAUSE OF DEATH IS ANOXIC ENCEPHALOPATHY, DROWNING, SEIZURE DISORDER, AND BLUNT HEAD TRAUMA. THE EXPLANTED DEVICES HAVE NOT BEEN RECEIVED TO DATE. AN INTERNAL SUDEP EVALUATION WAS PERFORMED BY THE MANUFACTURER WHICH DETERMINED THE DEATH TO BE POSSIBLE SUDEP.

    Description of Event or Problem · 1

    THE EXPLANTED DEVICES WERE RECEIVED. IN THE 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. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS OF THE CURRENT AUTOMATED FINAL TEST. ANALYSIS IN THE LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. ANALYSIS ON THE LEAD HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTION. A LARGE 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 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. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTION OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217490 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2612

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death