BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2232302 · Received September 2, 2011

    Report

    Report Number
    1644487-2011-02054
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    December 1, 2010
    Report Date
    August 10, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR OT DISTRIBUTION. CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, CYBERONICS, OR CYBERONICS'; EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR "MALFUNCTIONS". THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND CYBERONICS OBJECTS TO THEIR USE.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE MANUFACTURER'S CONSULTANT REPORTED THAT THE VNS PATIENT HAD AN INFECTION AND THE VNS WAS REMOVED ABOUT 4 MONTHS AFTER IMPLANT. THE PATIENT HAD VNS RE-IMPLANTED ON (B)(6) 2011. THE MANUFACTURING RECORDS WERE REVIEWED AND THEY CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN HAVE BEEN TO NO AVAIL THUS FAR. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2518

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention