MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-15 for TRANSCUTANEOUS SPINAL CORD STIMULATION IRB# 14-000158 UNK manufactured by Neurorecovery Technologies.
| Report Number | MW5088070 |
| MDR Report Key | 8789084 |
| Date Received | 2019-07-15 |
| Date of Report | 2019-07-09 |
| Date of Event | 2015-11-13 |
| Date Added to Maude | 2019-07-15 |
| 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 | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS SPINAL CORD STIMULATION IRB# 14-000158 |
| Generic Name | STIMULATOR NEUROMUSCULAR EXTERNAL FUNCTION |
| Product Code | GZI |
| Date Received | 2019-07-15 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEURORECOVERY TECHNOLOGIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2019-07-15 |