MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-08-16 for NEUROMONICS TINNITUS TREATMENT PROCESSOR 100 NA manufactured by Neuromonics Inc..
[710793]
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.
Patient Sequence No: 1, Text Type: D, B5
[7855713]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005777056-2007-00001 |
| MDR Report Key | 903483 |
| Report Source | 05,07 |
| Date Received | 2007-08-16 |
| Date of Report | 2007-08-14 |
| Date of Event | 2007-07-17 |
| Date Mfgr Received | 2007-07-17 |
| Device Manufacturer Date | 2007-05-01 |
| Date Added to Maude | 2007-08-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 2810 EMRICK BLVD. |
| Manufacturer City | BETHLEHEM PA 18020 |
| Manufacturer Country | US |
| Manufacturer Postal | 18020 |
| Manufacturer Phone | 4848211260 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROMONICS TINNITUS TREATMENT |
| Generic Name | TINNITUS MASKER |
| Product Code | KLW |
| Date Received | 2007-08-16 |
| Returned To Mfg | 2007-07-30 |
| Model Number | PROCESSOR 100 |
| Catalog Number | NA |
| Lot Number | PID05217 |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 878681 |
| Manufacturer | NEUROMONICS INC. |
| Manufacturer Address | 2810 EMRICK BLVD. BETHLEHEM PA 18020 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-08-16 |