BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 7490505 · Received May 7, 2018

    Report

    Report Number
    1644487-2018-00717
    Event Type
    Injury
    Date Received
    May 7, 2018
    Date of Event
    March 20, 2018
    Report Date
    May 7, 2018
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFT? CODE 81- DEVICE EVALUATION IS NOT NECESSARY AS THE REPORTED EVENTS ARE NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE.

    Description of Event or Problem · 1

    REPORT RECEIVED THAT A PATIENT DEVELOPED AN INFECTION AT THE GENERATOR INCISION SITE. THE GENERATOR WAS IMPLANTED ONLY TWO WEEKS PRIOR TO THIS INFECTION BEING REPORTED. IT WAS ALSO REPORTED THAT THE PATIENT PICKED AT THE GENERATOR SITE. THE DHR OF THE GENERATOR AND LEAD INDICATED THEY HAD BEEN STERILIZED PER SPECIFICATION PRIOR TO BEING RELEASED FOR DISTRIBUTION. FURTHER INFORMATION WAS RECEIVED THAT THE VNS SYSTEM WAS EXPLANTED. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332470 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 5498 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention