BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 1230025 · Received November 12, 2008

    Report

    Report Number
    1644487-2008-02733
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    August 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - DEVICE MANUFACTURING RECORDS WERE REVIEWED. RESULTS - REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PATIENT'S GENERATOR REVISION SURGERY, THE WOUND HAD BROKEN OPEN. THE GENERATOR AND LEAD WERE SUBSEQUENTLY REMOVED. THE EXPLANTED PRODUCT WAS RETURNED TO THE MANUFACTURER AND WAS MARKED AS "INFECTED". PRODUCT ANALYSIS OF THE GENERATOR REVEALED NO ANOMALIES. REVIEW OF MANUFACTURING RECORDS FOR BOTH, THE GENERATOR AND LEAD SHOWED THE PRODUCT TO BE STERILIZED PRIOR TO DISTRIBUTION. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 LYJ CYBERONICS INC 104

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention