MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for STIMWAVE FREEDOM STIMULATORS manufactured by Stimwave Technologies Incorporated.
[183352283]
Stimwave battery doesn't hold a charge, supposed to last 12 hours. The stim/wave wearable pad stopped working, carries stimulate to nerves via implanted stimwave implants. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093691 |
| MDR Report Key | 9823644 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-11 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| 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 | STIMWAVE FREEDOM STIMULATORS |
| Generic Name | STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) |
| Product Code | GZB |
| Date Received | 2020-03-11 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STIMWAVE TECHNOLOGIES INCORPORATED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |