FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 8800602
·
Received July 17, 2019
Report
- Report Number
- 3006630150-2019-03638
- Event Type
- Injury
- Date Received
- July 17, 2019
- Date of Event
- June 27, 2019
- Report Date
- July 17, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767749
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5123531/5123532/5123686, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592696 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-70 | 5117060 | 08714729767749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |