MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-10-21 for STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM FR8A-RCV-A0; FR8A-TRL-B0 manufactured by Stimwave Technologies Inc..
| Report Number | 3010676138-2019-00037 |
| MDR Report Key | 9213683 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-21 |
| Date of Event | 2019-09-13 |
| Date Mfgr Received | 2019-09-23 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2019-10-21 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ELIZABETH GREENE |
| Manufacturer Street | 1310 PARK CENTRAL BOULEVARD S. |
| Manufacturer City | POMPANO BEACH FL 33064 |
| Manufacturer Country | US |
| Manufacturer Postal | 33064 |
| Manufacturer Phone | 8009655134 |
| Manufacturer G1 | STIMWAVE TECHNOLOGIES INC. |
| Manufacturer Street | 1310 PARK CENTRAL BOULEVARD S. |
| Manufacturer City | POMPANO BEACH FL 33064 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33064 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIMQ PERIPHERAL NERVE STIMULATOR (PNS) SYSTEM |
| Generic Name | PERIPHERAL NERVE STIMULATOR |
| Product Code | GZF |
| Date Received | 2019-10-21 |
| Model Number | FR8A-RCV-A0; FR8A-TRL-B0 |
| Lot Number | SWO180404; SWO180404 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STIMWAVE TECHNOLOGIES INC. |
| Manufacturer Address | 1310 PARK CENTRAL BOULEVARD S. POMPANO BEACH FL 33064 US 33064 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-21 |