FDA Adverse Event
Injury
Summary report: N
INFINION? CX
MDR report key: 23794771
·
Received December 12, 2025
Report
- Report Number
- 3006630150-2025-11420
- Event Type
- Injury
- Date Received
- December 12, 2025
- Date of Event
- September 12, 2025
- Report Date
- February 27, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL PRO CODE: QRB.
Additional Manufacturer Narrative · 0
ADDITIONAL PRO CODE: QRB.
Description of Event or Problem · 0
IT WAS REPORTED THE SPINAL CORD STIMULATION (SCS) LEAD DISPLAYED HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WERE NO ABNORMALITIES, AND THE ISSUE HAS RESOLVED. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE MEDICAL FACILITY.
Description of Event or Problem · 0
IT WAS REPORTED THE SPINAL CORD STIMULATION (SCS) LEAD DISPLAYED HIGH IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHERE THE LEAD WAS REMOVED AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WERE NO ABNORMALITIES, AND THE ISSUE HAS RESOLVED. THE EXPLANTED LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2711809 | INFINION? CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2317-70 | 7074966 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |