REACTIV8
Report
- Report Number
- 3013017877-2022-00024
- Event Type
- Malfunction
- Date Received
- December 21, 2022
- Date of Event
- November 30, 2022
- Report Date
- February 6, 2023
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- PMA / PMN Number
- P190021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MML REFERENCE # (B)(4).
THE LEAD ASSEMBLY WAS RETURNED AND EVALUATED. THE REPORTED ISSUE WAS VERIFIED. THE ANALYSIS CONFIRMED THAT LEAD CONDUCTOR FRACTURES WERE THE CAUSE OF THE OUT -OF-RANGE IMPEDANCE CONDITIONS OBSERVED WITH THE RIGHT PERCUTANEOUS STIMULATION LEAD. A REVIEW OF THE IMPLANT DOCUMENTATION INDICATES THE LEAD MODEL WAS THE OLD LEAD (8000-45). THE 8000-45 LEAD IS NO LONGER USED FOR IMPLANTS. MML REFERENCE #(B)(4).
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING INSUFFICIENT THERAPY AND HAS PAIN LEVEL OF 6.5 TO 10. THE FIELD CLINICAL ENGINEER (FCE) CONFIRMED THAT THE RIGHT ELECTRODE WAS OUT-OF-RANGE. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE RIGHT STIMULATION LEAD TO ADDRESS THE ISSUE. THE REVISION SURGERY WAS SUCCESSFUL WITH NO REPORT OF PATIENT HARM OR SURGERY.
IT WAS REPORTED THAT THE PATIENT WAS RECEIVING INSUFFICIENT THERAPY AND HAS PAIN LEVEL OF 6.5 TO 10. THE FIELD CLINICAL ENGINEER (FCE) CONFIRMED THAT THE RIGHT ELECTRODE WAS OUT-OF-RANGE. REVISION SURGERY WAS PERFORMED TO REMOVE AND REPLACE THE RIGHT STIMULATION LEAD TO ADDRESS THE ISSUE. THE REVISION SURGERY WAS SUCCESSFUL WITH NO REPORT OF PATIENT HARM OR SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2024771 | REACTIV8 | REACTIV8 PERCUTANEOUS STIMULATION LEAD | QLK | MAINSTAY MEDICAL LIMITED | 8000-45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Female |