BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1131042 · Received August 20, 2008

    Report

    Report Number
    1644487-2008-01956
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 24, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VNS PT DEVELOPED AN INFECTION AT THE GENERATOR SITE AFTER UNDERGOING GENERATOR REVISION SURGERY. THE PT PULLED OUT A SUTURE AND BECAME INFECTED. THE PT'S DEVICE WAS EXPLANTED. A REVIEW OF THE MFG RECORDS FOR THE GENERATOR SHOWED THE DEVICE TO BE STERILIZED PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention