MAUDE Adverse Event Report: Impulse Dynamics USA, Inc. OPTIMIZER Smart Mini; Implantable Pulse Generator

Model Number	CCM X11
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an initial implantation procedure of an osm ipg, the physician needed to reposition a lead after connecting ipg to both leads.The set screws were backed out too far and fell out of the threads.Impulse dynamics field representatives attempted to guide the physician through the process of re-seating the screw.Physician attempted to remove the seal plug to re-seat the set screw but in doing so damaged the seal plug.A backup device was provided and was successfully connected to the leads after lead repositioning was complete.The original ipg was decontaminated at an approved decontamination facility before being returned to impulse dynamics usa for evaluation.Damage was observed on the seal plug of the v1 distal setscrew which was consistent with the reported complaint description.After removing the damaged seal plug the setscrew was able to tighten down successfully.Visual inspection of the setscrew revealed no stripping or other damage.All 6 setscrews were then tightened to full depth and backed out without any issues.Testing of the electronic controls passed all checks.The root cause of this issue was determined to be user error during the implant procedure.During the procedure, the physician was instructed on how to re-seat the backed-out v1 distal setscrew but was unable to do so without damaging the seal plug.

• Brand Name: OPTIMIZER Smart Mini
• Common Device Name: Implantable Pulse Generator
• Manufacturer (Section D): Impulse Dynamics USA, Inc.; 401 route 73 n; bldg 50, ste 100; marlton NJ 08053
• Manufacturer Contact: christian toto ; 401 route 73 n; bldg 50, ste 100; marlton, NJ 08053 ; +1(856)434-7921
• MDR Report Key: 50258203
• Report Number: 3012563838-2026-00063
• Device Sequence Number: 10688016
• Product Code: QFV
• UDI-Device Identifier: 00810003380098
• UDI-Public: 00810003380098
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180036/S007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/04/2026
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H5275
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown