FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER?
MDR report key: 23522844
·
Received November 11, 2025
Report
- Report Number
- 3006630150-2025-10251
- Event Type
- Injury
- Date Received
- November 11, 2025
- Date of Event
- October 21, 2025
- Report Date
- January 26, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6). BATCH: 7073320/5041043 UDI: (B)(4). UDI: (B)(4).
Additional Manufacturer Narrative · 0
CORRECTION TO FU MDR IN BLOCKS H6.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. PATIENT WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2582058 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 375750 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention |