BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 3081806 · Received April 29, 2013

    Report

    Report Number
    1644487-2013-01187
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    October 1, 2012
    Report Date
    April 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENT AGE AT THE TIME OF THE EVENT. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED CORRECTING THE EVENT DATE. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    Description of Event or Problem · 1

    FOLLOW-UP SHOWED THAT THE INFECTION WAS FIRST OBSERVED IN (B)(6) 2012. THE INFECTION WAS AT THE CHEST AND NECK, AND CULTURES WERE TAKEN WITH NO GROWTH. THE DEVICES WERE EXPLANTED, AND THE PATIENT WAS STILL ON TREATMENT. THE RELATIONSHIP OF THE INFECTION TO VNS WAS UNKNOWN, BUT THE SURGEON SUSPECTED ACNE. THE GENERATOR WAS EXPLANTED ON (B)(6) 2013 AND THE LEAD WAS REMOVED ON (B)(6) 2013. THE PRODUCTS HAVE NOT BEEN RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT A PATIENT WAS EXPLANTED ON (B)(6) 2013 DUE TO AN INFECTION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    THE PATIENT'S EXPLANTED PRODUCTS HAVE NOT BEEN LOCATED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185887 PULSE GEN MODEL UNKNOWN GENERATOR LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention