FDA Adverse Event
Injury
Summary report: N
PRECISION?
MDR report key: 24976043
·
Received April 24, 2026
Report
- Report Number
- 3006630150-2026-02587
- Event Type
- Injury
- Date Received
- April 24, 2026
- Date of Event
- May 1, 2019
- Report Date
- April 24, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767688
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D2B: LGW - QRB.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISCOMFORT AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE AND THE IPG WAS NO LONGER WORKING AS INTENDED. THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 246074 | PRECISION? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110-02 | 15381169 | 08714729767688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female | Required Intervention |