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	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an osm ipg implant procedure, the v1 pin was set in the header, then removed by physician because the pin was not visualized completely to the back of the header.On second attempt, the v1 (middle) port distal set screw did not engage with the hex wrench.After attempting for 20-plus minutes, the physician made a clinical decision to implant a different ipg.The original ipg was decontaminated at an approved decontamination facility and was returned to impulse dynamics usa for evaluation.The evaluation noted the following: "the ipg is operating as expected.It was observed that the v1 distal port screw was backed out of the threads too far and was slightly sideways.After realigning the threads, the screw was able to be set and torqued as expected.All other set screws were set and torqued." the root cause was identified as user error: since the v1 pin was not fully inserted into the port after starting to set the screws, the physician backed the screw out of the port too far to reinsert the pin.By backing out the screw too far, the threads were unable to be realigned quickly so the physician asked for a new device.

• 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: 50258136
• Report Number: 3012563838-2026-00042
• Device Sequence Number: 10247287
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 07/06/2023
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H4700
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2023
• 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