BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3951313 · Received July 22, 2014

    Report

    Report Number
    1644487-2014-01851
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 25, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INITIALLY, IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT FOR AN UNKNOWN REASON. DURING THE VISIT THE PHYSICIAN NOTED THAT THE LEAD WAS PROTRUDING FROM THE PATIENT'S NECK. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT'S GENERATOR WAS COMING OUT OF THE PATIENT'S CHEST AREA. IT WAS REPORTED THAT THE EXTRUSION WAS APPROXIMATELY ONE CENTIMETER IN SIZE. THE SURGEON'S OFFICE REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN ON (B)(6) 2014 WHERE THE GENERATOR WAS OBSERVED STICKING OUT OF THE PATIENT'S SKIN. THE SURGEON PERFORMED EMERGENCY SURGERY ON (B)(6) 2014 AT WHICH TIME THE GENERATOR WAS EXPLANTED. IT WAS REPORTED THAT IT WAS BELIEVED THAT THE GENERATOR WAS NOT REPLACED. IT WAS REPORTED THAT THE PATIENT IS VERY THIN AND THE SURGEON MAY PERFORM A GRAFT IN THE FUTURE TO SEE IF THIS HELPS. IT WAS REPORTED THAT FRICTION OF THE PATIENT'S THIN SKIN WAS BELIEVED TO BE THE CAUSE OF THE EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428865 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS INC 102R 202073

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention