BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1790084 · Received August 6, 2010

    Report

    Report Number
    1644487-2010-01811
    Event Type
    Injury
    Date Received
    August 6, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A VNS PT'S TREATING NEUROLOGIST CALLED AND REPORTED THAT THEY HAD A VNS PT WHO WAS RECENTLY IMPLANTED WHOSE VNS LEAD AND GENERATOR SITE APPEARED INFECTED. THE PT WAS PLACED ON ANTIBIOTICS AND IS BEING REFERRED BACK TO SEE THEIR SURGEON. GOOD FAITH ATTEMPTS THUS FAR HAVE BEEN UNSUCCESSFUL IN ATTAINING ANY FURTHER DETAILS ABOUT THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2594

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention