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

Model Number	CCM X11
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An impulse dynamics field representative reported that after a second lead dislodgement occurred in a patient implanted with an optimizer lite ipg, the patient and doctor agreed to have the ipg and leads removed.The rep attended the explant procedure.The explanted ipg was returned to impulse dynamics usa in marlton, nj for evaluation.There is no evidence at this time that the ipg was malfunctioning at the time of explant.It is unclear as to the reason(s) why the leads repeatedly dislodged in this patient (ex.Anatomy, twiddler's, etc.) prior to system explant.

• Brand Name: OPTIMIZER Lite
• 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: 50793418
• Report Number: 3012563838-2026-00075
• Device Sequence Number: 9443222
• Product Code: QFV
• UDI-Device Identifier: 00810003380142
• UDI-Public: 00810003380142
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180036/S021
• 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): 09/16/2026

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: 05/18/2026
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B502-3-XX
• Device Lot Number: H5188
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2024
• 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: Male