FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 17160932
·
Received June 20, 2023
Report
- Report Number
- 3006630150-2023-03510
- Event Type
- Injury
- Date Received
- June 20, 2023
- Date of Event
- November 8, 2021
- Report Date
- July 10, 2023
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861614
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(6), BATCH: 7072399.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD MODERATE PAIN RELIEF DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD MODERATE PAIN RELIEF DUE TO HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REVISION PROCEDURE WAS A LEAD REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463554 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 7071600 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Required Intervention |