FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 16917598
·
Received May 12, 2023
Report
- Report Number
- 3006630150-2023-02695
- Event Type
- Injury
- Date Received
- May 12, 2023
- Date of Event
- April 24, 2023
- Report Date
- May 12, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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)(6), BATCH: 7115936. PRODUCT FAMILY: SCS-IPG-PC, UPN: M365SC14160, MODEL: SC-1416, SERIAL: (B)(6), BATCH: 212502.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED AND PATIENT EXPERIENCED LOSS OF STIMULATION. THE PATIENT UNDERWENT AN EXPLANT AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE RETAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1309647 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7115859 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female | Required Intervention |