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

Model Number	CCM X11
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an initial implantation procedure of an osm ipg, the v2 lead would not remain seated in the connector block.The lead consistently backed out without any applied forward pressure, suggesting possible air or resistance within the port.Multiple connection attempts were made.Each time, once both set screws were engaged, significant noise was observed on the egm, more pronounced in bipolar mode but present in both bipolar and unipolar.A backup device was connected, and the case was completed without further issue.The original ipg was decontaminated at an approved decontamination facility before being returned to impulse dynamics usa for evaluation.Device interrogation and log analysis revealed no irregularities.X-ray imaging of the unit showed no abnormalities.The electronic control test leads were securely connected to the ipg ports for testing with no difficulties encountered.The ipg passed all electronic control tests without issue.A go/no-go gauge pin set was used to confirm that the port dimensions were within specification.While within spec, the measurements may be near the tolerance limit.No functional abnormalities were identified during evaluation.The device passed final electronic control testing and x-ray imaging showed no issues.Port dimensions were verified to be within specification using a go/no-go gauge.However, there was an indication they may be near the tolerance limit which may have contributed to the lead insertion challenges observed during implantation.The root cause is most likely mechanical variation at the edge of acceptable port dimensions, which affected ease of lead insertion during the procedure.Additionally, the reduced port volume could have trapped air, creating resistance during lead insertion due to limited space for air displacement, potentially contributing to the observed difficulty.

• 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: 50258201
• Report Number: 3012563838-2026-00066
• Device Sequence Number: 10688014
• 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: 2026
• Device Explanted Year: 2026
• 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: 10/04/2026
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H5298
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/17/2025
• 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: 09/02/2024
• 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