BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROMONICS TINNITUS TREATMENT

    MDR report key: 903483 · Received August 16, 2007

    Report

    Report Number
    3005777056-2007-00001
    Event Type
    Other
    Date Received
    August 16, 2007
    Date of Event
    July 17, 2007
    Report Date
    August 14, 2007
    Manufacturer
    NEUROMONICS INC.
    Product Code
    KLW
    PMA / PMN Number
    K043274
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEUROMONICS DEVICE KEEPS A LOG OF DEVICE USAGE IN MEMORY THAT CAN BE DOWNLOADED AND REVIEWED BY CLINICIANS TO ASSIST WITH DISCUSSION AT FOLLOW-UP APPOINTMENTS. UPON RETURN OF THE DEVICE TO NEUROMONICS, THIS DATA WAS DOWNLOADED. REVIEW OF DEVICE USAGE DATA FROM THE DEVICE DOES NOT SHOW ANY USE BEYOND 06/26/2007. TESTING OF THE DEVICE UPON RETURN TO NEUROMONICS (08/10/2007) INDICATES THAT IT IS FUNCTIONAL.

    Description of Event or Problem · 1

    WHILE THERE HAS BEEN NO CLAIM OF A DEVICE MALFUNCTION, THE FOLLOWING INCIDENT OCCURRED TO A PT THAT HAD PREVIOUSLY USED THE NEUROMONICS TINNITUS TREATMENT. HISTORY: THE PERSON CONCERNED HAD A TIRE BLOW UP NEXT TO HIS EAR IN 2007. HE HAD SIGNIFICANT DISTURBANCE FROM TINNITUS AND HYPERACUSIS AFTERWARDS. THE PT VISITED THE CLINICIAN AND WANTED TO PROCEED WITH THE NEUROMONICS TINNITUS TREATMENT. THE PT PRESENTED WITH REACTIVE TINNITUS, AND WAS HIGHLY DISTURBED BY HIS TINNITUS. THE PT WAS FITTED WITH THE NEUROMONICS TINNITUS TREATMENT TWO MONTHS LATER. SIX DAYS LATER, THE PT CLAIMED TO HAVE REACTIVE TINNITUS (WHERE MANY IF NOT ALL ENVIRONMENTAL SOUNDS MAY EXACERBATE THE TINNITUS). HAVING REPORTED REACTIVE TINNITUS, THE CLINICIAN MOVED THE PATIENT TO THE 2ND PHASE OF TREATMENT. A TINNITUS COACH/PSYCHOLOGIST WAS RECOMMENDED ON 6/08/2007. FOURTEEN DAYS LATER, THE PT REPORTEDLY HAD HIS REACTIVE TINNITUS UNDER CONTROL AND WAS USING THE NEUROMONICS TINNITUS TREATMENT. ON 6/28/2007, A PSYCHIATRIST REPORTEDLY RECOMMENDED THAT THE PT CEASE USING THE DEVICE UNTIL HE HAD HIS ANXIETY AND STRESS UNDER CONTROL. THERE IS NO EVIDENCE OF DEVICE USAGE AFTER THIS DATE. THE PT ALSO SOUGHT TREATMENT FROM A SECOND CLINICIAN, THEN REPORTEDLY ATTEMPTED SUICIDE ON OR BEFORE THE NEXT MONTH AND WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONICS TINNITUS TREATMENT TINNITUS MASKER KLW NEUROMONICS INC. PROCESSOR 100 PID05217

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization THE PT WAS REPORTEDLY ON UNSPECIFIED MEDICATION.