FDA Adverse Event
Injury
Summary report: N
INFINION CX
MDR report key: 12686122
·
Received October 22, 2021
Report
- Report Number
- 3006630150-2021-05948
- Event Type
- Injury
- Date Received
- October 22, 2021
- Date of Event
- June 10, 2021
- Report Date
- October 22, 2021
- 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
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE OF EVENT: 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: M365SC2317500, MODEL:SC-2317-50, SERIAL: (B)(4), BATCH: 5093122.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENTS LEAD APPEARED TO HAVE SHIFTED AND WAS NO LONGER WORKING. IT WAS ALSO NOTED THAT THE PATIENT HAD CONTACTS OUT ON ONE OF THE PERCUTANEOUS LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED PER HOSPITAL POLICY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1581541 | INFINION CX | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION | SC-2317-50 | 5092845 | 08714729861614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |