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

Model Number	CCM X10
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During a lead revision procedure of an os ipg, the new lead couldn't be fixed in the header of the ipg despite screwing a few times.The physician opted to explant and replace the ipg.The explanted ipg was decontaminated at an approved decontamination facility and returned to impulse dynamics usa for evaluation.Damage was observed at the top of the ipg on both sides; however, all 6 set screws could be fully torqued and then retracted without issue.The defect reported by the physician could not be replicated or confirmed.The root cause of this event is likely due to improper lead positioning during implant.

• 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: 50258149
• Report Number: 3012563838-2026-00046
• Device Sequence Number: 18673251
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 07/27/2020
• Device Model Number: CCM X10
• Device Catalogue Number: 10-B411-3-XX
• Device Lot Number: H4095
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/17/2024
• 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