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	10/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the initial implantation procedure of an osm ipg, the physician removed the lead from header to reposition the lead.When attempting the reconnect the lead into the header, the distal set screw would not go in.The physician was unable to reseat the set screw after multiple attempts.A backup ipg was ultimately implanted without incident.The original ipg was decontaminated at an approved decontamination facility before being returned to impulse dynamics usa for evaluation.X-rays taken upon its return showed no misalignment of the setscrews.The set screw hardware itself was functioning correctly and was not faulty.All setscrews were successfully driven to full depth and backed out without any issues when using a hex wrench.Testing of the electronic controls passed all checks.After a more detailed examination of the x-rays, it was observed that the v2 distal screw block was slightly misaligned.Additional testing by the product development team confirmed that, despite the slight misalignment, it remained within specifications.Since the setscrews were confirmed to be functional and not misaligned, the root cause of the difficulty in reseating the distal set screw is likely a result of user technique.The physician may not have properly aligned the lead or header when attempting to reinsert the lead, which could have prevented the screw from engaging or going in fully.

• 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: 50258190
• Report Number: 3012563838-2026-00060
• Device Sequence Number: 15957660
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/09/2026

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: 05/08/2026
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H5172
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/21/2024
• 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: 04/04/2024
• 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