FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 18866811
·
Received March 8, 2024
Report
- Report Number
- 3006630150-2024-01344
- Event Type
- Injury
- Date Received
- March 8, 2024
- Date of Event
- December 20, 2023
- Report Date
- March 8, 2024
- 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
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). BATCH: 7072539. PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC11600. MODEL: SC-1160. SERIAL: (B)(6). BATCH: 368888.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT HAD INADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE LEADS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED WITH AN MRI COMPATIBLE DEVICE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 989653 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 5161268 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention |