FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 17854010
·
Received October 2, 2023
Report
- Report Number
- 3006630150-2023-05973
- Event Type
- Injury
- Date Received
- October 2, 2023
- Date of Event
- September 8, 2023
- Report Date
- October 2, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7132369.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEG PAIN FOLLOWING AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE LEADS HAD MIGRATED AS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A PROCEDURE TO REVISE THE LEADS, HOWEVER DURING THE PROCEDURE, CEREBROSPINAL FLUID (CSF) WAS LEAKING FROM THE MIDLINE INCISION. THE PHYSICIAN OPTED TO EXPLANT THE LEADS AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1341553 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7131218 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female | Required Intervention |