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	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An impulse dynamics field representative based in italy reported that a patient implanted with an os ipg reported hearing a clicking sound within the device pocket without any associated pain or sensation.Upon placing the charger over the device, the error code 2 was displayed.The id field rep restarted the ipg, and therapy resumed successfully.However, approximately 30 minutes after the follow-up, the patient experienced the clicking sound again.When the charger was repositioned over the device, the error code reappeared.The device was again checked, and therapy had again been deactivated, so it was restarted.We observed the patient for another hour, but the incident occurred once again.Restart was again performed.Today, the patient is still reporting a code 2 error.The physician decided to refer the patient for a lead and/or ipg revision.The leads were confirmed to be intact and functional, so the physician replaced the os ipg with a new osm ipg without incident.The explanted os ipg was decontaminated at an approved decontamination facility before being returned to impulse dynamics usa for evaluation.The device passed all final electronic controls testing.Product development reviewed the device logs which showed 5 instances of "log_enter_permanent_high_curr" resulting in a code 2 alert.The ccm amplitude was set to 7.5 v, and the ccm lead impedance was less than 300 ohms.A code 2 alert is a diagnostic alert typically indicating a device function issue like charging abnormalities.In this case, the code 2 alert was a result of multiple instances of high charging current.The root cause of this occurrence was determined to be the combination of a high ccm amplitude setting (7.5 v) and a low lead impedance (<300 ohms).It is a normal occurrence for a charge with a high voltage through a low impendance load to result in high current.

• 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: 50258202
• Report Number: 3012563838-2026-00067
• Device Sequence Number: 10688015
• 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: 2018
• 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 Model Number: CCM X10
• Device Catalogue Number: 10-B411-3-XX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2025
• 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