FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 12073737
·
Received June 28, 2021
Report
- Report Number
- 3006630150-2021-03261
- Event Type
- Injury
- Date Received
- June 28, 2021
- Date of Event
- April 20, 2021
- Report Date
- June 28, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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: (B)(4). MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 5100212.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF AND DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED. THE EXPLANTED DEVICES WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 970195 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5094178 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |