FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 18314825
·
Received December 12, 2023
Report
- Report Number
- 3006630150-2023-07813
- Event Type
- Injury
- Date Received
- December 12, 2023
- Date of Event
- September 1, 2023
- Report Date
- December 12, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: COVEREDGE, UPN: M365SC8452700, MODEL: SC-8452-70, SERIAL: (B)(6), BATCH: 7071239.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION IN THE LOWER BACK FROM THE SPINAL CORD STIMULATOR (SCS) SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1384049 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 542678 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Unknown | Required Intervention |