BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 532686 · Received July 2, 2004

    Report

    Report Number
    1644487-2004-00566
    Event Type
    Injury
    Date Received
    July 2, 2004
    Date of Event
    April 1, 2004
    Report Date
    May 17, 2004
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS PT WAS EXPERIENCING INTERMITTENT SHORTNESS OF BREATH WITH STIMULATION. THE PT HAD PREVIOUSLY EXPERIENCED FLU-LIKE SYMPTOMS AND SOME SHORTNESS OF BREATH SEVERAL WEEKS EARLIER, BUT WAS NOW ALSO HAVING PAIN AT THE GENERATOR SITE. THE PT IS REPORTEDLY EXPERIENCING GOOD EFFICACY WITH THE VNS THERAPY AND THERE IS NO REDNESS OR SWELLING NOTED AT THE GENERATOR SITE. DEVICE DIAGNOSTIC TESTING WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION. REVIEW OF X-RAYS REVEALED NO OBVIOUS DISCONTINUITIES IN THE NCP SYSTEM. THE PT REPORTS NO RECENT INJURY OR TRAUMA THAT MAY HAVE DAMAGED THE NCP SYSTEM BUT DID INDICATE LIFTING HEAVY OBJECTS WHILE ON THE JOB. PROGRAMMED OUTPUT CURRENT WAS REDUCED FROM 1.25MA TO 1.0MA. FURTHER FOLLOW-UP REVEALED THAT TREATING EPILEPTOLOGIST REFERRED PT TO NEUROSURGEON FOR REPLACEMENT OF THE ENTIRE NCP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 3536

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention DATE OF MFG 06/03/1998, STERILIZATION LOT NO.11887| MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE 6/30/00,| ZARONTIN, MAXALT, VIOXX, NAPROXEN.| MEDICATIONS AT TIME OF EVENT INCLUDE: DEPAKOTE,