FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 21658320
·
Received March 20, 2025
Report
- Report Number
- 3006630150-2025-01674
- Event Type
- Injury
- Date Received
- March 20, 2025
- Date of Event
- February 24, 2025
- Report Date
- March 20, 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: EXACT DATE UNKNOWN, EXPLANT DATE USED AS THE APPROXIMATED DATE OF EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317500, MODEL:SC-2317-50, SERIAL: (B)(6), BATCH: 7073567.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT LEAD REPLACEMENT PROCEDURE. THE EXPLANTED DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 338408 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2317-50 | 7020945 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |