FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA
MDR report key: 21541735
·
Received March 6, 2025
Report
- Report Number
- 3006630150-2025-01299
- Event Type
- Injury
- Date Received
- March 6, 2025
- Date of Event
- February 13, 2024
- Report Date
- March 6, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729985099
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(4). BATCH: 7073423/ 7073428/ 7073438/ 7073427.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE STIMULATION. THE PATIENT UNDERWENT SPINAL CORD STIMULATOR (SCS) EXPLANT PROCEDURE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487609 | WAVEWRITER ALPHA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 504009 | 08714729985099 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Required Intervention |