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	Bacteremia (4846)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, an impulse dynamics field representative was informed that a patient had their osm ipg and leads explanted that day.The patient had developed an infection around their implanted port-a-cath device, which had been implanted due to the patient's ongoing cancer treatment.The physician elected to explant all of the patient's implanted devices, which included an osm ipg.Hospital blood cultures identified bacteremia as the type of infection around the port-a-cath.The explanted osm ipg and leads are currently being held under quarantine at the hospital.The ipg is expected to be received by impulse dynamics usa in (b)(6) in the coming weeks to be further evaluated.There is no evidence at this time to indicate the ipg caused or contributed to the patient's infection.

• 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 ; 8564347921
• MDR Report Key: 23513489
• Report Number: 3012563838-2025-00026
• Device Sequence Number: 9770266
• Product Code: QFV
• UDI-Device Identifier: 00810003380142
• UDI-Public: 00810003380142
• Combination Product (Y/N): N
• PMA/510(K) Number: P180036/S021
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

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: 10/18/2025
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B502-3-XX
• Device Lot Number: H5075
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/10/2025
• 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