FDA Adverse Event
Injury
Summary report: N
LINEAR ST
MDR report key: 9517818
·
Received December 25, 2019
Report
- Report Number
- 3006630150-2019-07637
- Event Type
- Injury
- Date Received
- December 25, 2019
- Date of Event
- November 15, 2019
- Report Date
- December 25, 2019
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729767725
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7071033, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.
Description of Event or Problem · 1
A REPORT WAS RECEIVED THAT THE PATIENTS STIMULATION PROGRAMS WERE CAUSING PAIN AND WEIRD MUSCLE SENSATIONS. IT WAS ALSO REPORTED THAT THE STIMULATION WAS INADEQUATE AND WAS NOT COVERING THE TARGET AREAS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1312401 | LINEAR ST | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2218-50 | 5172490 | 08714729767725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |