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

Model Number	CCM X11
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	Twiddlers Syndrome (4563)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an osm ipg presented for a pocket revision and lead reposition due to twiddlers.Lead repositioning was accomplished and the pocket was revised.Post-implant communication with the device was unachievable and the physician felt it was most likely due to her having not charged the device for a few weeks.The physician advised the patient to charge the ipg overnight, but the next day, the hospital np advised the impulse dynamics field representative that the patient was unable to charge as planned.The rep began trying to charge the device by repositioning the charger antennae and interrogate the device with the intelio.The device was unable to be charged and interrogated, and was replaced the next day.The explanted ipg was decontaminated at an approved decontamination facility and was returned to impulse dynamics usa for evaluation.It was not possible to interrogate the device.The can was opened, and the operation of the circuit was observed.The power rail was correct, indicating intact fuse and sufficient battery voltage.Both microcontrollers were observed to be executing.The communication lines between the telemetry microcontroller and the radio module indicated that the microcontroller was attempting to communicate with the radio, but it was not responding to those attempts.A power on reset was forced, after which the device communicated normally.It was found in down_mics_initchip_failed.It was successfully reset, the removed can portion was replaced and held in place with tape, and the unit passed the aets testing.This reinitialization error caused by the zarlink communication chip was addressed as part of a subsequent firmware update approved by fda (p180036/s037).

• 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: 50258147
• Report Number: 3012563838-2026-00044
• Device Sequence Number: 10125056
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 06/03/2023
• Device Model Number: CCM X11
• Device Catalogue Number: 10-B501-3-XX
• Device Lot Number: H4681
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/24/2023
• 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
• Date Device Manufactured: 05/06/2021
• 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: Female