BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1822436 · Received August 26, 2010

    Report

    Report Number
    1644487-2010-01948
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT SHE HAD A PT THAT HAD DEVELOPED A SMALL HEMATOMA AT THEIR VNS INCISION SITE. ONE WEEK PRIOR TO THIS REPORTED EVENT, THE PT HAD SURGERY TO HAVE A PROPHYLACTIC REPLACEMENT OF THEIR VNS GENERATOR RELATED TO MIGRATION. THE PT'S FAMILY REPORTED THAT THE AREA AROUND THE GENERATOR WAS RED AND SWOLLEN. THE PT'S TREATING SURGEON BELIEVES THEIR HEMATOMA FORMATION WAS DUE TO PT MANIPULATION AND ADDITIONALLY THE BLOOD ACCUMULATION WAS DUE TO A PLATELET ISSUE WHICH THEY ARE TRYING TO RESOLVE. THE PT'S VNS SITE WAS DRAINED AND SUTURED AND NOW IT HAS SLIGHTLY REOCCURRED, BUT THERE ARE NO PLANS AT THIS TIME TO REMOVE THE GENERATOR. DEVICE FUNCTION WAS REPORTED TO HAVE BEEN CHECKED AND CONFIRMED WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 201296

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R