BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3892377 · Received June 24, 2014

    Report

    Report Number
    1644487-2014-01577
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS ON THE GENERATOR WAS COMPLETED. REVIEW OF THE DATA INDICATED THAT THE PULSEDISABLED BYTE WAS SET TO A VALUE THAT REPRESENTS A VBAT<EOS THRESHOLD CONDITION. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, INDICATING THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE IMPLANT, WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR. A RESET OF THE PULSEDISABLE BIT IN THE GENERATOR MEMORY WAS PERFORMED TO ALLOW FOR AN OUTPUT TO ONCE AGAIN BE PROVIDED BY THE GENERATOR FOR SUBSEQUENT TESTING. 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. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE BATTERY, 2.989 VOLTS AS MEASURED SHOWS A NON-IFI CONDITION. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 0.816% OF THE BATTERY HAD BEEN CONSUMED. OTHER THAN THE NOTED EVENT, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED STATUS SEIZURES AND DEVICE DIAGNOSTICS SHOWED EOS: YES. IT WAS REPORTED THAT THE PATIENT HAD RECENTLY HAD THE GENERATOR REPOSITIONED AND ELECTROCAUTERY WAS USED. THE PATIENT WAS SCHEDULED FOR GENERATOR REPLACEMENT. THE RELATIONSHIP OF THE STATUS SEIZURES TO VNS THERAPY IS UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY ON (B)(6) 2014 DUE TO PATIENT ADVERSE EVENTS. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367555 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 3840

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention