BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3070867 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01107
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 29, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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

    REPORTER INDICATED A PATIENT DEVELOPED A MILD INFECTION THE VNS GENERATOR SITE IN THE CHEST FOLLOWING VNS GENERATOR REPLACEMENT SURGERY ON (B)(6) 92013. THE INFECTION IS FELT TO BE RELATED TO THE GENERATOR REPLACEMENT SURGERY. IT IS UNKNOWN IF ANY INTERVENTIONS WERE DONE. THE INFECTION HAS NOW RESOLVED AND IS NO LONGER AN ISSUE. THERE WAS NO TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172601 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 202430

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other