MAUDE Adverse Event Report: Impulse Dynamics USA, Inc. OPTIMIZER Lite; 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	05/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During the initial implantation procedure of an optimizer lite ipg, the physician reported the v2 setscrew could not be engaged.Physician made numerous attempts to reengage the setscrew but was unsuccessful.After many attempts to reengage the setscrew, the physician stated that the ipg was defective and requested another ipg.A backup ipg was implanted without incident.The original ipg was decontaminated at an approved decontamination facility before being returned to impulse dynamics usa for evaluation.Damage was observed on one of the v2 setscrews consistent with the reported issue.The hexagonal edges of the setscrew were fully stripped.The remaining five setscrews were successfully tightened to full depth and backed out without any issues.To proceed with electronic controls testing, the damaged setscrew was replaced.The device then passed all functional checks.The reported issue occurred when the v2 setscrew on the ipg could not be engaged during the implant procedure.Based on the evaluation of the returned device, the setscrew was found to be completely stripped, preventing proper engagement with the torque tool.This damage is consistent with repeated attempts to engage the screw after initial misalignment or improper tool insertion.It is likely that the setscrew was damaged during these early attempts, rendering it non-functional for the remainder of the procedure.The root cause of the failure is mechanical damage to the setscrew, likely resulting from repeated unsuccessful engagement attempts, possibly initiated by initial tool misalignment or excessive force.

• Brand Name: OPTIMIZER Lite
• 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: 50258200
• Report Number: 3012563838-2026-00065
• Device Sequence Number: 13433935
• Product Code: QFV
• UDI-Device Identifier: 00810003380142
• UDI-Public: 00810003380142
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180036/S021
• 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: 12/13/2025
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B502-3-XX
• Device Lot Number: H5094
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2025
• 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
• 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