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	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A contracted field representative in spain noted that during an initial implantation procedure of an osm ipg, the v1 electrode screw didn't make the "crack" sound that indicates its locking while lead impedance was high (above 2000 ohms).When checked with a psa, impedance was fine (850 ohms), so the physician opted to use the backup ipg instead, which was 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 return clearly showed the v1 electrode setscrew misaligned, which was consistent with the reported complaint description.This setscrew could not be returned to the proper position in its cavity when attempting to engage it with a hex wrench due to the severe misalignment.The other 5 set screws were run to full depth and back out with no issues observed.The root cause of this issue was determined to be user error: the set screw was most likely excessively unscrewed causing it to fully back out and become misaligned.This misalignment prevented it from being returned to the proper positions in its cavity.

• 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: 50258169
• Report Number: 3012563838-2026-00055
• Device Sequence Number: 9863045
• 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: Foreign,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: 01/31/2026
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H5116
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/10/2024
• 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
• 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