BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3132554 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01615
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    January 23, 2012
    Report Date
    May 2, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THE GENERATOR MET ALL FINAL TESTING REQUIREMENTS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ADDITIONAL INFORMATION SHOWS THAT THE EVENT DATE IS THE DATE OF IMPLANT; THEREFORE, THE PATIENT AGE AT THE TIME OF THE EVENT IS BEING UPDATED. DATE OF EVENT, CORRECTED DATA: ADDITIONAL INFORMATION SHOWS THAT THE EVENT DATE IS THE DATE OF IMPLANT.

    Description of Event or Problem · 1

    THE GENERATOR ANALYSIS WAS COMPLETED ON (B)(6) 2013. THE POST BURN-IN ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE CALCULATED (FROM RAM AND FLASH DATA) VBAT VOLTAGE WAS FOUND TO BE LOWER THAN THE ACTUAL BATTERY VOLTAGE (AS MEASURED WITH A DMM WHILE THE BATTERY WAS STILL ATTACHED TO THE PCB). THE LOW VBAT RESULTED IN THE DEVICE REPLACEMENT NOTIFICATIONS (IFI = YES, NEOS, ETC.) EVEN THOUGH THE ACTUAL BATTERY VOLTAGE WAS ABOVE THE WARNING LEVEL, THIS IS MOST LIKELY RELATED TO THE EXPOSURE FROM ELECTRO-CAUTERY USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS REPLACED ON (B)(6) 2013 DUE TO PREMATURE END OF SERVICE. TJE DEVICE WAS RETURNED AND IS PENDING PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT IT WAS FELT A PATIENT¿S VNS GENERATOR HAD REACHED AN IFI = YES CONDITION (8-18% BATTERY CAPACITY REMAINING) PREMATURELY. THE PATIENT HAS BEEN IMPLANTED WITH THE VNS SINCE (B)(6) 2012. THE PATIENT HAS BEEN AT THE SAME SETTINGS (2MA/20HZ/250 PULSE WIDTH) AND 29% DUTY CYCLE. THE REPORTER CONFIRMED THAT THE PATIENT HAD NO RECENT SURGERIES IN WHICH ELECTROCAUTERY WAS USED. ALL ATTEMPTS FOR ADDITIONAL PROGRAMMING HISTORY FROM THE REPORTER HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    REVIEW OF ADDITIONAL DECODER DATA FROM (B)(6) 2012 TO (B)(6) 2013 SHOWS THAT THE DEVICE WAS FIRST INTERROGATED ON (B)(6) 2012 AT EOS PULSE DISABLED (0/30/500/30/5/0/500/60). THIS INDICATES THAT THE DEVICE WAS LIKELY HIT WITH ELECTROCAUTERY DURING DEVICE IMPLANT. THIS WOULD ACCOUNT FOR THE DECREASED IN GENERATOR LONGEVITY. A PREVIOUS INVESTIGATION CONCLUDED THAT DEVICES HIT WITH ELECTROCAUTERY WOULD EXPERIENCE A 48% DECREASED IN BATTERY LIFE: THIS IS CONSISTENT WITH THIS SUSPECT MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236434 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201739

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR