FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 18799891
·
Received February 28, 2024
Report
- Report Number
- 3006630150-2024-01045
- Event Type
- Injury
- Date Received
- February 28, 2024
- Date of Event
- January 16, 2024
- Report Date
- February 28, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7090288/7090352.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 932007 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-1232 | 566193 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |