BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2000224 · Received February 17, 2011

    Report

    Report Number
    1644487-2011-00283
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT A VNS PT WAS HAVING SEIZURES ABOVE PRE-VNS BASELINE SINCE HIS PROPHYLACTIC GENERATOR REPLACEMENT. VNS GENERATOR'S DIAGNOSTICS WERE OK AND NO MALFUNCTION IS SUSPECTED. THERE HAS BEEN NO MEDICATION OR PROGRAMMING CHANGES AND NEUROLOGIST IS NOT SURE IF INCREASE SEIZURE IS RELATED TO VNS THERAPY. NO INTERVENTIONS HAVE BEEN PLANNED SO FAR PER NEUROLOGIST. MFR REVIEWED PT'S X-RAY IMAGES. THE ALIGNMENT OF THE POSITIVE AND NEGATIVE ELECTRODE APPEARED TO BE NORMAL. THERE WERE STRAIN RELIEF BEND AND LOOP PRESENT. THE LEAD WAS ROUTED TOWARDS THE GENERATOR. THE GENERATOR WAS PLACED ON THE LEFT CHEST AND A SMALL AMOUNT OF LEAD WAS PLACED BEHIND THE GENERATOR. THE CONNECTOR PIN APPEARED TO BE FULLY INSERTED. THE FILTER FEED-THRU WIRES APPEARED TO BE INTACT. THE LEAD ALSO APPEARED TO BE INTACT AT THE CONNECTOR PIN. NO OBVIOUS ANOMALIES COULD BE IDENTIFIED IN VISUALIZED PORTION OF THE PT'S VNS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 2751

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention