FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 21106951
·
Received January 8, 2025
Report
- Report Number
- 3006630150-2024-09347
- Event Type
- Injury
- Date Received
- January 8, 2025
- Date of Event
- December 12, 2024
- Report Date
- January 8, 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
- FL, 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/SCS-LEAD FIXATION UPN: M365SC2218500/M365SC43180 MODEL: SC-2218-50/SC-4318 SERIAL: (B)(6) BATCH: 7151072/34620570. PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160 MODEL: SC-1416 SERIAL: (B)(6) BATCH: 228054.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT UNDERWENT EXPLANT PROCEDURE DUE TO MIDLINE INCISION HAD OPENED AND WAS DRAINING. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS KEPT BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1396556 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7150456 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Female | Required Intervention |