BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1843801 · Received September 22, 2010

    Report

    Report Number
    1644487-2010-02147
    Event Type
    Injury
    Date Received
    September 22, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A NURSE IN (B)(6) REPORTED TO OUR COUNTRY MANAGER THAT A VNS PATIENT WHO WAS IMPLANTED THE (B)(6) HAD AN INFECTION AT THE GENERATOR SITE. ANTIBIOTICS DID NOT RESOLVE THE PATIENT'S INFECTION. THE INFECTION WAS FIRST NOTED ON (B)(6) 2010 AS THERE WAS SWELLING AT THE GENERATOR SITE. AN INCISION AND DRAINAGE WAS PERFORMED ON (B)(6) FOR EVACUATION OF PUS AND THE PATIENT HAD A POSITIVE CULTURE THAT WAS SENSITIVE TO OXACILLINE AND AMOXI-CLAVULANE ACID. THE PATIENT RECEIVED AUGMENTIN 3X300 MG AND DESPITE THE TREATMENT HAD A 104 FEVER AND SWELLING OVER THE GENERATOR AGAIN. ON (B)(6) EXPLORATORY SURGERY WAS DONE, NO PUS WAS SEEN, CULTURES WERE TAKEN AGAIN AND THE POCKET SITE WAS CLEANED WITH POVIDENE IODINE, CULTURE TAKEN WAS GRAM +. AND CONTAINED (B)(6). THE PATIENT HAD THEIR VNS SYSTEM EXPLANTED AND IT IS AT THE MANUFACTURE PENDING COMPLETION OF PRODUCT ANALYSIS. THE PARENTS OF THE PATIENT DO NOT THINK THERE WAS ANY TRAUMA OR MANIPULATION AT THE GENERATOR OR NECK SITES THAT MAY HAVE ATTRIBUTED TO THIS INFECTION EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R