FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 20510274
·
Received October 22, 2024
Report
- Report Number
- 3006630150-2024-07231
- Event Type
- Injury
- Date Received
- October 22, 2024
- Date of Event
- October 8, 2024
- Report Date
- October 22, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- 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: 7110348.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION. X-RAY CONFIRMED THAT THE SPINAL CORD STIMULATION (SCS) LEADS MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE PHYSICIAN PULLED THE LEADS TO RE-POSITION THEM. POST OPERATIVELY, THE PATIENT WAS DOING WELL AND RECEIVING EXCELLENT STIMULATION COVERAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319231 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2218-50 | 7113212 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Required Intervention |