FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 14490631
·
Received May 24, 2022
Report
- Report Number
- 3006630150-2022-02439
- Event Type
- Injury
- Date Received
- May 24, 2022
- Date of Event
- May 2, 2022
- Report Date
- May 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
- NY, US
- 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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(4). BATCH: 5131408.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION AFTER HAVING A BACK SURGERY BY DIFFERENT SURGEON UNRELATED TO ORIGINAL PAIN. IT WAS NOTED THAT THE LEADS WERE MIGRATED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE KEPT BY FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1516826 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5086464 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Female | Required Intervention |