FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 8170152
·
Received December 17, 2018
Report
- Report Number
- 3006630150-2018-62309
- Event Type
- Injury
- Date Received
- December 17, 2018
- Date of Event
- December 5, 2018
- Report Date
- December 17, 2018
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5081244, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS ADJUSTED AND A NEW LEAD WAS ADDED FOR IMPROVED COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1011405 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-70 | 5073725 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |