MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-10-12 for RAPID? 4800-00T manufactured by The Magstim Company Limited.
[123489423]
Device involved: 4800-00t - rapid therapy system, which consisted of: 3012-00t - rapid? Mainframe - sn (b)(4) - manufacturing date november 2015; 3013-us - power supply unit - sn (b)(4) - manufacturing date october 2015; 3022-00t - user interface - sn (b)(4) - manufacturing date november 2015; 3801-01 - mains filter - sn (b)(4) - manufacturing date october 2015; 3910-00 - air film coil - sn (b)(4) - manufacturing date february 2016. Investigation initiated. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123489424]
It was reported that a patient came to the customer for transcranial magnetic stimulation for the treatment of major depressive disorder. Initial mapping was completed, the motor threshold determined to be 71%. Treatment was started at 60% determined by the patient's ability to tolerate. Proceeded with 10 trains at tolerable power of 60%. The patient became lightheaded and disoriented. The procedure was stopped. The supervising physician took the patient's blood pressure: 96/68. Cold sweat over entire body, signs of possible seizure present: disorientations, confusion, feet turned inwards, eyes rolled back briefly. The seizure lasted approximately 2 minutes. The supervising physician stayed with the patient until orientated and blood pressure returned to normal. The patient was allowed to leave the office as physical and mental symptoms abated. The patient was referred to primary (pcp) and cardiologist for recommended eeg and ekg. The current status of the patient is unknown due to unsuccessful attempts made by the practice to reach the patient by phone or email.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021774-2018-00003 |
| MDR Report Key | 7959544 |
| Report Source | USER FACILITY |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-09-11 |
| Date Facility Aware | 2018-09-12 |
| Report Date | 2018-09-12 |
| Date Reported to Mfgr | 2018-09-12 |
| Date Mfgr Received | 2018-09-12 |
| Date Added to Maude | 2018-10-12 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS INEKE BOEK |
| Manufacturer Street | SPRING GARDENS |
| Manufacturer City | WHITLAND, CARMARTHENSHIRE SA340HR |
| Manufacturer Country | UK |
| Manufacturer Postal | SA34 0HR |
| Manufacturer G1 | THE MAGSTIM COMPANY LIMITED |
| Manufacturer Street | SPRING GARDENS |
| Manufacturer City | WHITLAND, CARMARTHENSHIRE SA340HR |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SA34 0HR |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID? |
| Generic Name | RAPID? THERAPY SYSTEM |
| Product Code | OBP |
| Date Received | 2018-10-12 |
| Model Number | 4800-00T |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE MAGSTIM COMPANY LIMITED |
| Manufacturer Address | SPRING GARDENS WHITLAND, CARMARTHENSHIRE SA340HR UK SA34 0HR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-12 |