BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1864292 · Received October 7, 2010

    Report

    Report Number
    1644487-2010-02248
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT EXPERIENCED AN INFECTION TWO WEEKS AFTER RE-IMPLANT OF A VNS GENERATOR. THE SURGEON SAW THE PT TWO WEEKS AFTER IMPLANT TO REMOVE THE STITCHES AND TWO DAYS LATER, THE PT'S MOTHER INDICATED THE AREA WAS SWOLLEN AND RED. THE PT WAS TAKEN TO THE SURGEON AND WAS GIVEN IV ANTIBIOTICS. THE PT'S VNS WAS EXPLANTED AND NOT RE-IMPLANTED DUE TO THE REPORTED INFECTION. FOLLOW-UP WITH THE SURGEON'S OFFICE INDICATED THAT THE CAUSE OF THE INFECTION WAS RELATED TO REPLACEMENT OF THE BATTERY AS THE CULTURES WERE POSITIVE FOR STAPH AUREUS ON THE LEFT AXILIA. THE PT'S GENERATOR AND LEAD WERE REMOVED ON (B)(6) 2010 AND NO PT MANIPULATION WAS REPORTED TO HAVE CONTRIBUTED TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 201423

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention