FDA Adverse Event
Injury
Summary report: N
INFINION? CX
MDR report key: 22769242
·
Received August 11, 2025
Report
- Report Number
- 3006630150-2025-06350
- Event Type
- Injury
- Date Received
- August 11, 2025
- Date of Event
- July 22, 2025
- Report Date
- August 11, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 08714729861614
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500 MODEL: SC-2317-50 SERIAL: (B)(6) BATCH: 5110474 UDI: (B)(4). PRODUCT FAMILY: SCS-IPG-R-MRI UPN: M365SC12320 MODEL: SC-1232 SERIAL: (B)(6) BATCH: 557652 UDI: (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2003072 | INFINION? CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2317-50 | 5095801 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Required Intervention |