FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 8962642
·
Received September 4, 2019
Report
- Report Number
- 3006630150-2019-04805
- Event Type
- Injury
- Date Received
- September 4, 2019
- Date of Event
- August 15, 2019
- Report Date
- September 4, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5152000, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. IT WAS ALSO REPORTED THAT THE LEADS HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN ONE OF THE LEADS WAS RELOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756715 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5151994 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |