BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL 303

    MDR report key: 4113036 · Received September 24, 2014

    Report

    Report Number
    1644487-2014-02440
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 13, 2014
    Report Date
    August 27, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE INCORRECT SUSPECT DEVICE. DEVICE MANUFACTURE DATE, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE INCORRECT SUSPECT DEVICE. EVALUATION CODES, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY DID NOT REPORT THE DEVICE HISTORY RECORDS BEING REVIEWED AND REPORT THE RESULTS AND CONCLUSION CODES INCORRECTLY. MANUFACTURER DEVICE HISTORY RECORDS WERE REVIEWED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THE LEAD MET SPECIFICATIONS FOR STERILIZATION TESTING PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS EXPERIENCING PAIN AND POSSIBLY DEVELOPED AN INFECTION AT LEAD INCISION SITE. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS IDENTIFIED THAT A DUPLICATE REPORT OF THIS PATIENT'S INFECTION WAS SUBMITTED IN MFG REPORT #: 1644487-2014-02448. THIS REPORT WILL HOUSE ANY FUTURE INFORMATION RELATED TO THE INFECTION. IT WAS REPORTED THAT THE INFECTION MAY HAVE BEEN RELATED TO THE SUTURES FROM SURGERY, ALTHOUGH SURGERY WAS OVER A YEAR PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593243 LEAD MODEL 303 LEAD LYJ CYBERONICS, INC. 303-20 202132

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other