EVOKE SCS SYSTEM
Report
- Report Number
- 3021836309-2024-00194
- Event Type
- Injury
- Date Received
- February 13, 2024
- Date of Event
- January 17, 2024
- Report Date
- April 5, 2024
- 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
LEADS AND CLS ARE NOT AVAILABLE FOR ANALYSIS. WITHOUT THE DEVICES' RETURN, IT IS NOT POSSIBLE TO REACH A DEFINITIVE ROOT CAUSE REGARDING INADEQUATE THERAPY. IMPEDANCE LOGS REVEALED ALL ELECTRODES WERE WITHIN RANGE. THE CAUSE OF THE DEFORMED NON-ACTIVE BAND REMAINS UNCLEAR, ALTHOUGH THERAPY HAS RESUMED AFTER REVISION SURGERY WITH NO REPORTED ISSUES. THE MANUFACTURING RECORDS WERE REVIEWED. THE PRODUCT MET ALL REQUIREMENTS FOR RELEASE, WITH NO ANOMALIES IDENTIFIED. SECTION D4 AND H5 - AS THE DEVICE WAS UNKNOWN BOTH HAVE BEEN PROVIDED: 102316-15. MANUFACTURE DATE: 09NOV2020. EXPIRY DATE: 09NOV2022. OR 102655-49, MANUFACTURE DATE: 03DEC2020, EXPIRY DATE: 03DEC2022.
INVESTIGATION OF THIS EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS NOT RECEIVING ADEQUATE THERAPY. REPROGRAMMING WAS PERFORMED MULTIPLE TIMES WITHOUT THE DESIRED RESULT. A REVISION SURGERY WAS PERFORMED. DURING THE REVISION PROCEDURE, A DEFORMED NON-ACTIVE BAND WAS NOTED AFTER THE LEAD WAS REMOVED FROM THE CLS. IT IS UNKNOWN WHEN THE DEFORMATION OCCURRED OR WHETHER IT CONTRIBUTED TO THE INADEQUATE THERAPY. FOLLOWING THE PROCEDURE, THE PATIENT WAS RECEIVING ADEQUATE THERAPY.
A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM WAS NOT RECEIVING ADEQUATE THERAPY. REPROGRAMMING WAS PERFORMED MULTIPLE TIMES WITHOUT THE DESIRED RESULT. A REVISION SURGERY WAS PERFORMED. DURING THE REVISION PROCEDURE, A DEFORMED NON-ACTIVE BAND WAS NOTED AFTER THE LEAD WAS REMOVED FROM THE CLS. IT IS UNKNOWN WHEN THE DEFORMATION OCCURRED OR WHETHER IT CONTRIBUTED TO THE INADEQUATE THERAPY. FOLLOWING THE PROCEDURE, THE PATIENT WAS RECEIVING ADEQUATE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2136101 | EVOKE SCS SYSTEM | SCS LEAD | LGW | SALUDA MEDICAL PTY LTD | EVOKE 12C PERCUTANEOUS LEAD KIT - 60CM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |