FDA Adverse Event
Injury
Summary report: N
LINEAR 3-6
MDR report key: 11352142
·
Received February 19, 2021
Report
- Report Number
- 3006630150-2021-00567
- Event Type
- Injury
- Date Received
- February 19, 2021
- Date of Event
- February 8, 2021
- Report Date
- February 19, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789574
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXACT DATE UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366700; MODEL: SC-2366-70; SERIAL: (B)(4); BATCH: 5142489.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INSUFFICIENT STIMULATION TO THE AREA OF NEED. THE PHYSICIAN CONFIRMED DEVICE MIGRATION WITH X-RAY IMAGING, AND ASSESSED THAT THIS WAS LIKELY DUE TO GENERAL MOVEMENT AS THE LEADS WERE PLACE PERIPHERALLY AND NOT IN THE DORSAL COLUMN. THE PATIENT UNDERWENT A REVISION PROCEDURE TO MOVE THE LEADS AND IS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248370 | LINEAR 3-6 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2366-50 | 5141446 | 08714729789574 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |