BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2942412 · Received February 4, 2013

    Report

    Report Number
    1644487-2013-00285
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 9, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE HOSPITAL WILL NOT RELEASE THE PATIENT IMPLANT INFORMATION WITHOUT A SIGNED PATIENT RELEASE.

    Description of Event or Problem · 1

    THE GENERATOR AND LEAD WERE UNABLE TO BE LOCATED BY THE HOSPITAL AND THEY FELT THAT THE EXPLANTED PRODUCT MUST HAVE BEEN DISCARDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIS GENERATOR AND LEAD EXPLANTED. THE GENERATOR AND A PORTION OF THE LEAD WERE EXTRUDING AT THE GENERATOR INCISION IN THE CHEST. THE CAUSE OF THE EXTRUSION IS BELIEVED TO BE DUE TO A FOREIGN BODY RESPONSE. THERE IS NO INFECTION SUSPECTED. THE EXTRUSION WAS FIRST NOTICED ON (B)(6) 2012. THERE WERE NO ASSOCIATED SYMPTOMS OR INFECTION PRESENT. THERE WAS NO KNOWN MANIPULATION OR TRAUMA AND THE CAUSE OF THE EXTRUSION WAS UNKNOWN. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE IMPLANT HOSPITAL AND THEY PROVIDED THE PRODUCT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46715 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 2641

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention