FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 21382299
·
Received February 14, 2025
Report
- Report Number
- 3006630150-2025-00718
- Event Type
- Injury
- Date Received
- February 14, 2025
- Date of Event
- July 23, 2024
- Report Date
- February 14, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN APPROXIMATELY SIX MONTHS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 5110930.
Description of Event or Problem · 0
IT WAS REPORTED THAT PATIENT SPINAL CORD STIMULATOR LEAD HAD IMPEDANCES. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1489900 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2317-50 | 5110696 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Required Intervention |