FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 16331367
·
Received February 9, 2023
Report
- Report Number
- 3006630150-2023-00500
- Event Type
- Injury
- Date Received
- February 9, 2023
- Date of Event
- September 20, 2021
- Report Date
- February 9, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, 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, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5093388 / 7071728.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD LOST STIMULATION COVERAGE DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE. THE EXPLANTED LEADS WERE NOT RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1004427 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-70 | 3035830 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Required Intervention |