FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 15663789
·
Received October 24, 2022
Report
- Report Number
- 3006630150-2022-05727
- Event Type
- Injury
- Date Received
- October 24, 2022
- Date of Event
- August 1, 2022
- Report Date
- October 24, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861614
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2317500; MODEL: SC-2317-50; SERIAL: (B)(4); BATCH: 5063025.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS REPOSITIONED AND STILL IMPLANTED IN PATIENTS BODY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 391323 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5079503 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Female | Required Intervention |