FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 11268647
·
Received February 2, 2021
Report
- Report Number
- 3006630150-2021-00202
- Event Type
- Injury
- Date Received
- February 2, 2021
- Date of Event
- August 7, 2020
- Report Date
- February 2, 2021
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861638
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. MODEL NUMBER/CATALOG NUMBER: SC-2317-50, SERIAL NUMBER: (B)(4) , BATCH/LOT NUMBER: 5151774, MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 70CM. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING PATIENTS NON-DEVICE RELATED SURGERY THE PATIENTS LEADS HAVE BEEN DAMAGED CAUSING HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN LEADS WERE REPLACED AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165998 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 5149877 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |