FDA Adverse Event
Injury
Summary report: N
SPECTRA WAVEWRITER?
MDR report key: 23569205
·
Received November 17, 2025
Report
- Report Number
- 3006630150-2025-10452
- Event Type
- Injury
- Date Received
- November 17, 2025
- Date of Event
- August 11, 2023
- Report Date
- November 17, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729951254
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7070431, UDI: (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7070114, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND PAIN AT THE IPG SITE. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) AND SPINAL CORD STIMULATOR (SCS) LEADS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288436 | SPECTRA WAVEWRITER? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1160 | 363464 | 08714729951254 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Required Intervention |