FDA Adverse Event
Malfunction
Summary report: N
INFINION? PRO
MDR report key: 23821684
·
Received December 16, 2025
Report
- Report Number
- 3006630150-2025-11482
- Event Type
- Malfunction
- Date Received
- December 16, 2025
- Date of Event
- August 7, 2025
- Report Date
- January 21, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 00191506018733
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 3 MONTHS AGO PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) HAD FRACTURED AND WAS CONFIRMED BY X-RAY.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATOR (SCS) HAD FRACTURED AND WAS CONFIRMED BY X-RAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LEADS MIGRATED WHICH WAS CONFIRMED WITH IMAGING. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1943709 | INFINION? PRO | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2318-70 | 5002327 | 00191506018733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | Required Intervention |