FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 11398559
·
Received March 2, 2021
Report
- Report Number
- 3006630150-2021-00703
- Event Type
- Injury
- Date Received
- March 2, 2021
- Date of Event
- January 20, 2021
- Report Date
- March 2, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789581
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7070787.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION DUE TO LEAD MIGRATION. THE PATIENT FELT STIMULATION IN A DIFFERENT AREA AND WAS NO LONGER HELPING WITH THEIR HEADACHE PAIN. THE LEADS WERE MOVED BACK TO THEIR ORIGINAL POSITION AND THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298748 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-70 | 7070788 | 08714729789581 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |