FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 12146765
·
Received July 9, 2021
Report
- Report Number
- 3006630150-2021-03672
- Event Type
- Injury
- Date Received
- July 9, 2021
- Date of Event
- May 1, 2021
- Report Date
- July 9, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2021 FROM THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7090967. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7075315 / 7075845.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT LEAD REVISION PROCEDURE WHEREIN THE LEADS WHERE ADJUSTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1038756 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 7089556 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |