D
Patient 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NAUSEA AND VOMITING AFTER THE PATIENT TURNED ON THE STIMULATION. IT WAS UNKNOWN WHAT WAS THE CAUSE OF PATIENTS SYMPTOMS. THE PATIENT WAS HOSPITALIZED.
MAUDE MDR 9908474
- MDR report key
- 9908474
- Report number
- 3006630150-2020-01565
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-12
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- TALAR TAHMASIAN
- Address
- 25155 RYE CANYON LOOP VALENCIA CA 91355 US
- Phone
- 661-661-6619
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SPECTRA WAVEWRITER | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | BOSTON SCIENTIFIC NEUROMODULATION | LGW | SC-1160 | SC-1160 | 332834 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. H; 2. R |