FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 18750569
·
Received February 21, 2024
Report
- Report Number
- 3006630150-2024-00868
- Event Type
- Injury
- Date Received
- February 21, 2024
- Date of Event
- October 4, 2023
- Report Date
- February 21, 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
- SC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7072432,
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DUE TO THE LEAD HAVING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE NOT RETURNED AS THEY WERE DISPOSED BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1404969 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-70 | 5156266 | 08714729861638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention |