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

Model Number	CCM X10
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This os ipg was explanted on (b)(6) 2026.Previously, the patient reported that during last charging process, the device's battery indicator on the charger screen always remained at 4 bars.The patient continued to perform weekly charging in the last weeks even though they had no feedback from the charger battery indicator lights.An in-clinic follow-up resulted in this same charger behaviour despite the impulse dynamics field representative's use of either the patient's charger or fce charger.The ipg could not be interrogated using any available programmer; no blinking feedback light on the programmer wand turned on, and only the standby light was on.Only a couple of times, the charger was able to communicate with the device for a few seconds, resulting in an error code 2.It was decided by the patient's physician the ipg would be replaced, which occurred on (b)(6) 2026.The explanted ipg is expected to be received by impulse dynamics for further evaluation.

• Brand Name: OPTIMIZER Smart
• 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: 50258206
• Report Number: 3012563838-2026-00071
• Device Sequence Number: 10688018
• Product Code: QFV
• UDI-Device Identifier: 00810003380050
• UDI-Public: 00810003380050
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180036
• 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: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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 Model Number: CCM X10
• Device Catalogue Number: 10-B411-3-XX
• Device Lot Number: H5487
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2025
• 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