OPTIMIZER SMART MINI
Report
- Report Number
- 3012563838-2025-00028
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- December 17, 2025
- Report Date
- January 12, 2026
- Manufacturer
- IMPULSE DYNAMICS USA, INC.
- Product Code
- QFV
- UDI-DI
- 00810003380098
- PMA / PMN Number
- P180036/S007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DURING AN OSM IPG IMPLANTATION PROCEDURE ON (B)(6) 2025, IT WAS OBSERVED AND REPORTED BY AN IMPULSE DYNAMICS FIELD REPRESENTATIVE THAT ONE OF THE IPG SET SCREWS "EITHER FELL OUT OR WOULD NOT ENGAGE AFTER [ELECTROPHYSIOLOGIST] BACKED THE SCREW OUT TOO FAR." THIS RESULTED IN A NEW IPG BEING SELECTED FOR IMPLANT INSTEAD. NO OTHER INFORMATION HAS BEEN PROVIDED, BUT THE DEVICE IS EXPECTED TO BE RECEIVED BY IMPULSE DYNAMICS USA IN MARLTON, NJ IN THE COMING WEEKS FOR FURTHER EVALUATION.
NOTE: THIS IS AN AMENDMENT TO A PREVIOUSLY FILED MDR. THE IPG WAS RETURNED AND EVALUATED AFTER BEING STERILIZED. A LOOSE SET SCREW WAS OBSERVED THAT WAS CONSISTENT WITH THE REPORTED ISSUE. THE REMAINING FIVE SET SCREWS WERE SUCCESSFULLY TIGHTENED TO FULL DEPTH AND BACKED OUT WITHOUT ISSUE. TO PROCEED WITH ELECTRONIC CONTROLS TESTING, THE LOOSE SET SCREW WAS REPLACED. THE DEVICE THEN PASSED ALL FUNCTIONAL CHECKS OF THE FINAL ELECTRONIC CONTROLS TESTING. THE ROOT CAUSE OF THIS ISSUE WAS USER ERROR DURING THE IMPLANT PROCEDURE. THE IPG WAS SCRAPPED AFTER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1783677 | OPTIMIZER SMART MINI | IMPLANTABLE PULSE GENERATOR | QFV | IMPULSE DYNAMICS USA, INC. | CCM X11 | H5349 | 00810003380098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |