PRECISION?
Report
- Report Number
- 3006630150-2025-10225
- Event Type
- Injury
- Date Received
- November 11, 2025
- Date of Event
- January 1, 2021
- Report Date
- February 5, 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
- TN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER THE LAST SEVERAL YEARS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. BLOCK D2B: LGW, QRB.
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED OVER THE LAST SEVERAL YEARS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. BLOCK D2B: LGW, QRB.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT IMPLANTABLE PULSE GENERATOR (IPG) CHARGING. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. OLD BATTERY EXPLAINED AND KEPT BY FACILITY.
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT IMPLANTABLE PULSE GENERATOR (IPG) CHARGING. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE. PATIENT IS DOING WELL POSTOPERATIVELY. OLD BATTERY EXPLAINED AND KEPT BY FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 492947 | PRECISION? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110-02 | 13451951 | 08714729767688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Required Intervention |