FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 10817929
·
Received November 10, 2020
Report
- Report Number
- 3006630150-2020-05458
- Event Type
- Injury
- Date Received
- November 10, 2020
- Date of Event
- June 22, 2020
- Report Date
- November 10, 2020
- 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
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL : SC-2317-50, SERIAL : (B)(4), LOT: 5143583.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SCS PATIENT EXPERIENCED A LOSS OF STIMULATION TO THE NEEDED AREA DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS RE-POSITIONED BACK INTO PLACE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1285442 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5143211 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |