BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2831377 · Received November 14, 2012

    Report

    Report Number
    1644487-2012-02996
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    June 9, 2011
    Report Date
    October 22, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS INITIALLY REPORTED THAT THE VNS PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2012 DUE TO AN INFECTION. THE SURGEON LATER REPORTED THAT THE PATIENT HAD AN ELECTIVE REPLACEMENT OF HER VNS GENERATOR BACK ON (B)(6) 2011 BUT SUBSEQUENTLY DEVELOPED AN (B)(6) INFECTION. DESPITE A WASHOUT ON (B)(6) 2011 THE PATIENT ULTIMATELY UNDERWENT EXPLANATION OF THE GENERATOR AND PARTIAL LEADS ON (B)(6) 2011. THE PATIENT ACTUALLY HAD A NEW DEVICE IMPLANTED ON (B)(6) 2012, LONG AFTER THE INFECTION HAD RESOLVED; THERE WAS A LONG DELAY DUE TO FREQUENT PNEUMONIAS AND OTHER ILLNESSES. IT WAS ALSO NOTED THAT PRIOR TO THE SURGERY ON (B)(6) 2012 THE PATIENT WAS HAVING SEIZURES AGAIN. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE SURGEON HAVE BEEN MADE BUT HAVE BEEN UNSUCCESSFUL TO DATE. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION FOR BOTH THE LEAD AND GENERATOR PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 201697

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention