MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-11-21 for H-WAVE E STIMULATOR PT-A * manufactured by Electronic Wave Form, Lab Inc..
[20156227]
During physical therapy treatment, while lying supine, on h-wave electrical stimulator to neck (post) and upper trapezius (low), the pt was heard moaning. The pt then fell to the ground in what appeared to be a seizure, eye flutter "extremity tone," was unresponsive for approx 10-15 mins. Blood pressure 155/90, heart rate 96. Physician advised the pt be removed to the er for evaluation. The pt gradually regained consciousness prior to transfer to the er. Treating neurologist diagnosis of muscle contraction. No known lasting effects at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020473 |
| MDR Report Key | 305832 |
| Date Received | 2000-11-21 |
| Date of Report | 2000-11-14 |
| Date of Event | 2000-10-20 |
| Date Added to Maude | 2000-11-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | H-WAVE E STIMULATOR |
| Generic Name | H-WAVE E STIMULATOR |
| Product Code | JPF |
| Date Received | 2000-11-21 |
| Model Number | PT-A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 295984 |
| Manufacturer | ELECTRONIC WAVE FORM, LAB INC. |
| Manufacturer Address | 16168 BEACH BLVD #232 HUNTINGTON BEACH CA 92647 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-11-21 |