FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 19431057
·
Received May 30, 2024
Report
- Report Number
- 3006630150-2024-03506
- Event Type
- Injury
- Date Received
- May 30, 2024
- Date of Event
- May 11, 2024
- Report Date
- May 30, 2024
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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: M365SC2317700, MODEL: SC-2317-70 , SERIAL: (B)(6), BATCH: 7083070.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A LEAD REVISION PROCEDURE DURING WHICH THE LEAD WAS REPOSITIONED DUE TO LEAD MIGRATION. THE LEAD MIGRATION WAS CONFIRMED VIA COMPUTERIZED TOMOGRAPHY (CT) OR X-RAY IMAGING. THERE WERE NO REPORTED PATIENT SYMPTOMS DUE TO THE MIGRATION. THE PATIENT IS DOING WELL POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1275120 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 7081709 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |