FDA Adverse Event
Injury
Summary report: N
WAVEWRITER ALPHA?
MDR report key: 23164717
·
Received September 29, 2025
Report
- Report Number
- 3006630150-2025-08100
- Event Type
- Injury
- Date Received
- September 29, 2025
- Date of Event
- October 10, 2023
- Report Date
- September 29, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- 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: EXACT DATE UNKNOWN, EVENT OCCURRED IN 2023. D6B: EXPLANT DATE: (B)(6). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS. UPN: M365SC8336500. MODEL: SC-8336-50. SERIAL: (B)(6). BATCH: 7052695. UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEAD SITE. IT WAS UNKNOWN IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1305170 | WAVEWRITER ALPHA? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1232 | 584803 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | Required Intervention |