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

Model Number	CCM X11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An impulse dynamics field representative reported a patient implanted with an osm ipg developed a non-device-related infection that required the ipg be explanted.The explanted device was decontaminated at an approved decontamination facility before being returned to impulse dynamics usa for evaluation.The ipg was interrogated, and log data was reviewed, revealing no abnormalities.All electronic control tests on the ipg were successfully passed.It was determined that there was nothing functionally wrong with the device and the explant was only necessary due to the patient's infection.

• 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: 50258204
• Report Number: 3012563838-2026-00069
• Device Sequence Number: 18813458
• 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: 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: 04/16/2026
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H5155
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/25/2025
• 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