FDA Adverse Event
Injury
Summary report: N
LINEAR? ST
MDR report key: 22617635
·
Received July 25, 2025
Report
- Report Number
- 3006630150-2025-05892
- Event Type
- Injury
- Date Received
- July 25, 2025
- Date of Event
- July 7, 2025
- Report Date
- July 25, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7163155 UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE MIDLINE INCISION SITE. SYMPTOMS OF PAIN AND FEVER WERE NOTED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS PROCEDURE RELATED AND NOT DEVICE RELATED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED DEVICE COMPONENTS WERE KEPT BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 798015 | LINEAR? ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7163325 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention |