BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2100261 · Received May 16, 2011

    Report

    Report Number
    1644487-2011-01095
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS SCHEDULED TO HAVE HIS VNS DEVICE EXPLANTED. IT IS UNCLEAR AT THIS TIME IF THE EXPLANT OCCURRED AS SCHEDULED. THE PATIENT WAS REPORTEDLY SCHEDULED TO HAVE A DEEP BRAIN STIMULATION PROCEDURE.

    Description of Event or Problem · 1

    THE EXPLANTED LEAD AND GENERATOR WERE RETURNED TO THE MANUFACTURER ON (B)(4) 2012. PRODUCT ANALYSIS ON THE LEAD WAS COMPLETED. A SECTION OF THE LEAD ASSEMBLY WAS RETURNED FOR EVALUATION IN ONE PIECE. THE LEAD'S ELECTRODES WERE NOT RETURNED FOR EVALUATION. SETSCREW MARKS WERE SEEN ON THE CONNECTOR PIN, PROVIDING EVIDENCE THAT PROPER CONTACT BETWEEN THE SETSCREW AND THE LEAD PIN EXISTED AT LEAST ONCE. NOTE THAT SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATION, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. PRODUCT ANALYSIS ON THE EXPLANTED GENERATOR WAS COMPLETED. AN END OF SERVICE (EOS) CONDITION WAS FOUND IN THE PA LABORATORY. BASED ON THE ELECTRICAL TEST RESULTS, THE DEVICE EXHIBITED CURRENT CONSUMPTION RATES THAT ARE WITHIN SPECIFICATION, THEREBY DEMONSTRATING NORMAL BATTERY DEPLETION TO AN END-OF-SERVICE (EOS) CONDITION. THE PULSE GENERATOR MODULE 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 BY THE PHYSICIAN'S OFFICE THAT THE PATIENT'S DEVICE WAS NOT WORKING, AND HE WANTED IT OUT. ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2012, FROM THE SURGEON'S OFFICE INDICATING THAT THE SURGERY DID TAKE PLACE AS SCHEDULED. THEY WERE NOT ABLE TO PROVIDE ANY INFORMATION ON THE REASON FOR THE REPLACEMENT JUST THAT THE PATIENT WAS REPLACED. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PSYCHIATRIST'S OFFICE THAT THE PATIENT'S VNS WAS PREVIOUSLY EXPLANTED (AS PREVIOUSLY REPORTED), AND THE LEAD WAS ONLY REMAINING. HOWEVER FROM PREVIOUS INVESTIGATION, IT IS KNOWN THAT A PORTION OF THE LEAD WAS IN FACT EXPLANTED, AS A PORTION OF THE LEAD WAS RECEIVED BY THE MANUFACTURER FOR ANALYSIS. THE PATIENT IS REFERRED FOR DBS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 015644

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR