FDA Adverse Event
Injury
Summary report: N
LINEAR 3-4
MDR report key: 12663531
·
Received October 20, 2021
Report
- Report Number
- 3006630150-2021-05868
- Event Type
- Injury
- Date Received
- October 20, 2021
- Date of Event
- July 30, 2020
- Report Date
- October 20, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729789550
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7071005.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS REPROGRAMMED WAS STILL NOT GETTING PAIN COVERAGE. A FLUOROSCOPY WAS PERFORMED AND REVEALED THAT BOTH LEADS HAVE MIGRATED A VERTEBRAL BODY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1562114 | LINEAR 3-4 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2352-50 | 7070800 | 08714729789550 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |