FDA Adverse Event
Injury
Summary report: N
PRECISION?
MDR report key: 23286648
·
Received October 15, 2025
Report
- Report Number
- 3006630150-2025-08772
- Event Type
- Injury
- Date Received
- October 15, 2025
- Date of Event
- May 18, 2021
- Report Date
- November 17, 2025
- 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
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK D2B: PRO CODE (PRODUCT CODE): QRB.
Additional Manufacturer Narrative · 0
BLOCK D2B: PRO CODE (PRODUCT CODE): QRB.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER FUNCTIONING AS INTENDED. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE. BATTERY WAS DISPOSED OF PER FACILITY POLICY. ADDITIONAL INFORMATION STATED THAT THE PATIENT IS DOING WELL POSTOPERATIVELY.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NO LONGER FUNCTIONING AS INTENDED. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) EXPLANT PROCEDURE. BATTERY WAS DISPOSED OF PER FACILITY POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185064 | PRECISION? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110-02 | 187220 | 08714729767688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Required Intervention |