FDA Adverse Event
Injury
Summary report: N
EVOKE SCS SYSTEM
MDR report key: 15983526
·
Received December 14, 2022
Report
- Report Number
- 3012939358-2022-00126
- Event Type
- Injury
- Date Received
- December 14, 2022
- Date of Event
- November 7, 2022
- Report Date
- December 15, 2022
- Manufacturer
- SALUDA MEDICAL PTY LTD
- Product Code
- LGW
- PMA / PMN Number
- P190002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A PATIENT REPORT INFECTION OF THE IPG POCKET DURING HOSPITAL VISIT (B)(6) 2022), 27 DAYS FOLLOWING IMPLANT DATE. THE PATIENT EXPERIENCED NAUSEA, IMPLANT PAIN AND SWELLING AT THE IPG POCKET SITE. BLOOD SAMPLES INDICATED AN INFECTION. ANTIBIOTIC THERAPY WAS PRESCRIBED AND HAD RESOLVED AT FOLLOW UP VISIT ON 16 NOVEMBER 2022. IT WAS NOTED TO BE RELATED TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1626445 | EVOKE SCS SYSTEM | SCS IPG | LGW | SALUDA MEDICAL PTY LTD | EVOKE CLOSED LOOP STIMULATOR (CLS) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Hospitalization |