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

Model Number	CCM X11
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During the initial implant of an osm ipg, when tightening the v1 ring set screw, the doctor inserted the torque wrench, tightened the screw, and, upon removal of the torque wrench, the entire rubber gasket/gromet pulled out of the header.The impulse dynamics field representative observed the entire occurrence and observed the doctor's proper use of the torque wrench and set screw.The doctor then pointed out that the v2 anodal set screw gasket was also improperly set with half of the gasket halfway out of the header.The doctor was trying to move quickly because it took over an hour to attain access (normally takes about 10 minutes) and the rubber gasket/gromet came loose, which were put back into place.Before the id rep could offer if doctor wanted to use a different device, he requested medical silicone glue, broke scrub, left the room, and instructed the fellow to apply silicone adhesive to the gaskets and close.An investigation of the device records was conducted that led to the contract manufacturer opening a capa.It was noted that this ipg had been previously reworked by the cm prior to final id shipment and acceptance due to silicone sealing failure.The patient later passed away due to non-device-related reasons; the ipg remains implanted and is thus unavailable for further evaluation.

• 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: 50258179
• Report Number: 3012563838-2026-00054
• Device Sequence Number: 21297803
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: 03/01/2026
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H5129
• Was Device Available for Evaluation?: No
• 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): No
• 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: Male