FDA Adverse Event
Injury
Summary report: N
EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US)
MDR report key: 22196562
·
Received June 12, 2025
Report
- Report Number
- 3016111136-2025-00086
- Event Type
- Injury
- Date Received
- June 12, 2025
- Date of Event
- May 15, 2025
- Report Date
- June 12, 2025
- Manufacturer
- SALUDA MEDICAL PTY LTD
- Product Code
- LGW
- UDI-DI
- 09352307001640
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ADDITIONAL EXPLANTED DEVICE DETAILS: 2X LEADS FROM THE SAME LOT NUMBER. CLS: BRAND NAME - EVOKE CLOSED LOOP STIMULATOR (CLS), MODEL: 102901, CATALOG#: 3042, SERIAL NUMBER: (B)(6).
Description of Event or Problem · 0
A PATIENT IMPLANTED WITH AN EVOKE SPINAL CORD STIMULATION (SCS) SYSTEM, WAS EVALUATED FOR POSSIBLE INFECTION OF THE MIDLINE INCISION SITE. THE EVOKE SCS SYSTEM WAS EXPLANTED AND THE MIDLINE INCISION SITE WAS WASHED OUT. POST-EXPLANT, THE PATIENT REMAINED UNDER OBSERVATION AND WAS CONFIRMED TO BE RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1806600 | EVOKE CAP12 PERCUTANEOUS LEAD KIT - 60CM (US) | SCS LEAD | LGW | SALUDA MEDICAL PTY LTD | 102878 | 9017416807 | 09352307001640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| O |