BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1080753 · Received July 23, 2008

    Report

    Report Number
    1644487-2008-01674
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    May 1, 2008
    Report Date
    June 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT SHORTLY AFTER GENERATOR REPLACEMENT SURGERY, THE VNS PT OPENED THE CHEST INCISION AND PULLED OUT THE DEVICE. FURTHER FOLLOW UP WITH THE TREATING PHYSICIAN REVEALED THAT THE BULKY DRESSING AND THE "GLUE" THAT WAS USED TO CLOSE THE INCISION FOLLOWING SURGERY LIKELY BOTHERED THE PT. AS A RESULT, THE PT PICKED AT THE SITE, EVENTUALLY OPENING THE WOUND AND PULLING OUT THE DEVICE. THE PT HAS PROFOUND MENTAL RETARDATION. ADDITIONAL INFO RECEIVED FROM THE NURSING STAFF AT THE GROUP HOME WHERE THE PT IS CARED FOR, INDICATED THAT THE PT HAD PICKED AT THE GENERATOR INCISION SITE AFTER SURGERY DUE TO IRRITATION FROM BULKY DRESSING AND ENDED UP PULLING OUT THE LEAD. THE SURGEON THEN EXPLANTED THE GENERATOR AT A LATER DATE. AT THIS TIME, THE PT IS BEING EVALUATED TO SEE IF A RE-IMPLANT WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200774

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention