REACTIV8 SYSTEM
Report
- Report Number
- 3013017877-2022-00006
- Event Type
- Malfunction
- Date Received
- May 23, 2022
- Date of Event
- May 6, 2022
- Report Date
- September 30, 2022
- Manufacturer
- MAINSTAY MEDICAL LIMITED
- Product Code
- QLK
- UDI-DI
- 05391527772019
- PMA / PMN Number
- P190021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MML COMPLAINT REFERENCE NUMBER (B)(4).
MML COMPLAINT REFERENCE NUMBER (B)(4). A REVIEW OF THE POST-INITIAL IMPLANT PROCEDURE IMAGES AND PRE-REVISION SURGERY IMAGES BY THE REACTIV8 SUBJECT MATTER EXPERTS CONFIRMED THAT THE SURGEON PLACED THE LEAD SUB-OPTIMALLY. THE SURGEON WAS ADVISED AND RETRAINED ON THE PROPER PLACEMENT OF THE LEAD.
IT WAS REPORTED THAT THE PATIENT RECEIVED A REVISION SURGERY TO REPLACE THE RIGHT LEAD. THE PATIENT WAS UNABLE TO RUN THERAPY ON THE RIGHT ELECTRODE. THE REVISION SURGERY WAS SUCCESSFUL, WITH NO PATIENT HARM OR INJURY REPORTS. THE SURGEON IDENTIFIED AND CONFIRMED THAT THE RIGHT LEAD WAS DISLOCATED BASED ON THE IMAGES TAKEN BY THE SURGEON.
IT WAS REPORTED THAT THE PATIENT RECEIVED A REVISION SURGERY TO REPLACE THE RIGHT LEAD. THE PATIENT WAS UNABLE TO RUN THERAPY ON THE RIGHT ELECTRODE. THE REVISION SURGERY WAS SUCCESSFUL, WITH NO PATIENT HARM OR INJURY REPORTS. THE SURGEON IDENTIFIED AND CONFIRMED THAT THE RIGHT LEAD WAS DISLOCATED BASED ON THE IMAGES TAKEN BY THE SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 551802 | REACTIV8 SYSTEM | REACTIVE PERCUTANEOUS STIMULATION LEAD | QLK | MAINSTAY MEDICAL LIMITED | 8145 | 05391527772019 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |