FDA Adverse Event
Injury
Summary report: N
LINEAR? 3-4
MDR report key: 21971888
·
Received May 6, 2025
Report
- Report Number
- 3006630150-2025-03106
- Event Type
- Injury
- Date Received
- May 6, 2025
- Date of Event
- December 9, 2024
- Report Date
- May 6, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729789550
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6) BATCH: 7072559, UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160, MODEL: SC-1416, SERIAL: (B)(6) BATCH: 220215, UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) HAD HIGH IMPEDANCES. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AS EXPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1884819 | LINEAR? 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2352-50 | 7072770 | 08714729789550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention |