FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 13672446
·
Received March 4, 2022
Report
- Report Number
- 3006630150-2022-00856
- Event Type
- Injury
- Date Received
- March 4, 2022
- Date of Event
- April 6, 2021
- Report Date
- March 4, 2022
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 08714729861614
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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: 5172131.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DUE TO LEAD HAVING HIGH IMPEDANCES. THE PHYSICIAN BELIEVED THAT PATIENTS CERTAIN MOVEMENTS HAD CAUSED IMPEDANCES. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WAS KEPT BY THE FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1706320 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5169224 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Female | Required Intervention |