MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-19 for NEUROSTAR TMS THERAPY SYSTEM NEUROSTAR TMS 1.2 81-60000-000 manufactured by Neuronetics Inc..
[2242113]
On (b)(6) 2010, the treating psychiatrist contacted neuronetics to report an adverse event of retinal detachment. This occurred in a female patient after her 11th treatment and was reported by the patient upon her return for her 12th treatment the following day ((b)(6) 2010). The patient reported seeing 2 lines and a circle in her right eye, with an onset about 5 minutes after her 11th tms treatment was completed, and as she was leaving the clinic building. This visual phenomena differed from floaters that she had experienced in the past prior to tms exposure. The staff withheld treatment that day and refered her to the emergency ophthalmology clinic where she was diagnosed with a retinal tear and posterior vitreous detachment. Laser surgery was completed that day and the patient returned for treatment on (b)(6) 2010 and continued through treatments 12-14 w/o incident. After treatment 15, she reported black dots appearing in her right eye for 4-5 seconds. She saw her ophthalmologist that afternoon for her post surgery follow up and the ophthalmologist recommended that she stop tms treatment.
Patient Sequence No: 1, Text Type: D, B5
[9402948]
Upon initial report, the relationship of this event to the device was unclear, as the patient had other risk factors in her medical history that also could have accounted for the occurrence of a retinal tear (eg, untreated hypertension). Therefore, follow up information was requested from the clinic and the evaluating ophthalmologists to clarify the relationship of the event to treatment, leading to a delay in this report. Additional clinical information is therefore, still pending from the site at the time of this report. It is noted that there have been no clinical reports in the literature of retinal detachment associated with the use of tms, though movement of muscles in and around the eye has been observed. It is also noted that the tms treatment protocol being used in this patient was 1 pulse per second, right prefrontal treatment, which differs from the currently cleared treatment protocol described in the product labeling (i. E. , 10 pulse per second, left prefrontal treatment).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004824012-2010-00001 |
| MDR Report Key | 2227107 |
| Report Source | 05,06 |
| Date Received | 2011-08-19 |
| Date of Report | 2010-06-24 |
| Date of Event | 2010-04-29 |
| Date Mfgr Received | 2010-05-07 |
| Device Manufacturer Date | 2008-12-01 |
| Date Added to Maude | 2011-09-02 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROSTAR TMS THERAPY SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATION SYSTEM |
| Product Code | OBP |
| Date Received | 2011-08-19 |
| Model Number | NEUROSTAR TMS 1.2 |
| Catalog Number | 81-60000-000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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. Other; 2. Required No Informationntervention | 2011-08-19 |