MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-09-20 for NEUROSTAR TMS THERAPY SYSTEM 81-60000-000 manufactured by Neuronetics, Inc..
[15508228]
The pt is a (b)(6) man with mdd who had been receiving tms over the l-dlpc with stimulation parameters noted below. He noticed left eye floaters suddenly on (b)(6), just after tms session #26 on the left side. He saw an ophthalmologist on (b)(6). The ophthalmology exam revealed a new posterior vitreous detachment (pvd) on the left and an old vitreous detachment on the right. There was no retinal holes or tears. The ophthalmologist impression was that the pvd was unrelated to the tms. The pt had a single tms session on the right dorsolateral pfc on (b)(6). The ophthalmologist cleared pt to resume left-sided tms on (b)(6). After the 1st ophthalmologist visit, the tms treating physician specifically looked for eye movements or lid twitching during the tms treatments and asked the pt if he noted any visual change during the treatment session but neither he nor pt noted any movements. A second wave of acute floaters developed on (b)(6), after tms session # 35. He saw the ophthalmologist that afternoon who identified a new left retinal detachment which responded to laser treatment. The laser treatment has been holding well since (b)(6). The pt has made a good recovery of his visual function.
Patient Sequence No: 1, Text Type: D, B5
[15751594]
Treatment parameters - motor threshold: 0. 85. Treatment protocol: dlpfc at 20hz, 80% mt, 2 sec/28 sec x 1000 pulses followed by left dlfpc 20 hz at 119% mt, 2 sec on, 28 sec off, for 2400 pulses. These parameters differ from the treatment parameters specified in the neurostar tms therapy system user manual (10hz, 120%mt, 4 sec on/26 sec off, 300 pulses). After the initial visit to the ophthalmologist the treating physician and the ophthalmologist assessed the posterior vitreous detachment (pvd) as not tms related, but after the second ophthalmologist visit for the retinal tear, they assessed the retinal tear as tms related. The neuronetics assessment of the causality is that the pvd was not tms related, with risk factors of treated hypertension, diabetes, and evidence of prior pvd in the contralateral eye. The retinal tear is possibly tms related given the timing in relation to the tms treatment, but is still confounded by the risk factors mentioned above. The device service records were obtained and reviewed. Results of this found that the device was functioning as intended and there were no significant or atypical services performed to the subject device that would have an affect on or cause the medical event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004824012-2012-00002 |
| MDR Report Key | 2757435 |
| Report Source | 05 |
| Date Received | 2012-09-20 |
| Date of Report | 2012-09-20 |
| Date of Event | 2012-08-17 |
| Date Mfgr Received | 2012-08-23 |
| Device Manufacturer Date | 2010-04-01 |
| Date Added to Maude | 2012-09-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. JUDY WAYS, PHD |
| Manufacturer Street | 31 GENERAL WARREN BLVD |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6109814107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSTAR TMS THERAPY SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR |
| Product Code | OBP |
| Date Received | 2012-09-20 |
| Model Number | 81-60000-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURONETICS, INC. |
| Manufacturer Address | 31 GENERAL WARREN BLVD MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-09-20 |