FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 9729118
·
Received February 19, 2020
Report
- Report Number
- 3006630150-2020-00662
- Event Type
- Injury
- Date Received
- February 19, 2020
- Date of Event
- January 29, 2020
- Report Date
- February 19, 2020
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/ CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 5143740, MODEL/ CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENTS LEADS WERE BEING OUT OF THE EPIDURAL SPACE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193565 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 3052107 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |