MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-14 for NEUROSTAR TIMS THERAPY SYSTEM 81-00315-000 manufactured by Neuronetics Inc..
[2409754]
Patient is a (b)(6) woman with recurrent depression with ideas of reference requiring recent hospitalization. She has a generalized seizure disorder, with her last seizure occurring in 2010. She was receiving tms therapy for her depression. Approximately 19 minutes into her 64th tms session, she was noted to have generalized tonic-clonic seizure with loss of consciousness, lasting less than 3. 5 minutes, followed by approximately one hour of post-ictal disorientation. After recovering from her seizure, she was able to go home. The treatment protocol, 4 seconds of 10 pulse per second trains at 140% of motor threshold with a 26 second intertrain interval (total 2500 pulses) varied from the neurotics labeled treatment protocol, and exceeds the stimulation parameters recommended in treatment guidelines for safe use of tims (wasserman, 1998). Two days prior to the event, she self-discontinued her clonazepam without informing the tims treatment staff. The treating physician assessed the event as not device related, but rather caused by clonazepam withdrawal.
Patient Sequence No: 1, Text Type: D, B5
[9694296]
(b)(4) - the treating physician believes this event is not device related. Neuronetics believes that assessment of relatedness is confounded by the patient's history of a generalized seizure disorder, and the acute discontinuation of clonazepam. A role for tms is not ruled out, however, since seizures are known to occur with tms therapy in the presence of agents or conditions which lower a patient's seizure threshold including medications, a history of seizure, and the use of treatment parameters which exceed the guidelines for safe use of tms. These conditions related to the seizure are described in the neurostar tms therapy system user manual, "warnings: risk of seizure" wassermann, e. M. (1998). Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the international workshop on the safety of repetitive transcranial magnetic stimulation, 06/07/1996. Electroencephalography and clinical neurophysiology, 108(1), 1-16.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004824012-2012-00001 |
| MDR Report Key | 2495968 |
| Report Source | 05,06 |
| Date Received | 2012-03-14 |
| Date of Report | 2012-03-13 |
| Date of Event | 2012-02-17 |
| Date Mfgr Received | 2012-02-17 |
| Device Manufacturer Date | 2009-02-03 |
| Date Added to Maude | 2012-03-21 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. JUDY WAYS |
| Manufacturer Street | 31 GENERAL WARREN BOULEVARD |
| 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 TIMS THERAPY SYSTEM |
| Generic Name | TRANSCRANIAL MAGNETIC STIMULATOR (OBP) |
| Product Code | OBP |
| Date Received | 2012-03-14 |
| Model Number | 81-00315-000 |
| 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 BOULEVARD MALVERN PA 19355 US 19355 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-14 |