FDA Adverse Event
Injury
Summary report: N
PRECISION?
MDR report key: 23760192
·
Received December 9, 2025
Report
- Report Number
- 3006630150-2025-11291
- Event Type
- Injury
- Date Received
- December 9, 2025
- Date of Event
- November 15, 2019
- Report Date
- February 17, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729767688
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: QRB.
Additional Manufacturer Narrative · 0
BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: QRB. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH A SPINAL CORD STIMULATION (SCS) DEVICE UNDERWENT A REVISION PROCEDURE FOR AN UNSPECIFIED REASON. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WITH A SPINAL CORD STIMULATION (SCS) DEVICE UNDERWENT A REVISION PROCEDURE FOR AN UNSPECIFIED REASON. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2553555 | PRECISION? | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-1110-02 | 15647356 | 08714729767688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention |