FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 13825245
·
Received March 19, 2022
Report
- Report Number
- 3006630150-2022-01112
- Event Type
- Injury
- Date Received
- March 19, 2022
- Date of Event
- January 6, 2022
- Report Date
- March 18, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: 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: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7082585.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED AS CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN A PADDLE LEAD WAS IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED PER PHYSICIANS PREFERENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6936 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7075206 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Required Intervention |