BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERONICS NEUROCYBERNETIC PROSTHESIS

    MDR report key: 352302 · Received September 13, 2001

    Report

    Report Number
    1644487-2001-00503
    Event Type
    Injury
    Date Received
    September 13, 2001
    Date of Event
    August 1, 2001
    Report Date
    September 5, 2001
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PATIENT BEGAN TO HAVE RINGING IN LEFT EAR (MID TO 08/2001). WHEN PATIENT PRESSES ON EAR, THE PT HAS PAIN. THE NEXT MONTH THE PATIENT BEGAN TO HAVE SHAKING IN LEFT HAND. PATIENT HAS BEEN ON DILANTIN AND CLONAZAPAM UP UNTIL THE END OF 08/2001. PATIENT IS CURRENTLY ON NEUROTONIN (200MG 3 TIMES/DAY). PATIENT EXPLAINS THAT THE NEUROTONIN GIVES THE PT A TINGLING FEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41981 CYBERONICS NEUROCYBERNETIC PROSTHESIS NEUROSTIMULATOR LYJ CYBERONICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Disability MODEL 300 BIPOLAR LEAD.