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

Model Number	CCM X10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported that a patient implanted with an os ipg had their device deactivated during an impella implantation procedure.The patient initially requested the os ipg be turned back on, but before they could be seen in-person by an impulse dynamics field representative, they underwent a heart transplant.The explanted os ipg was discarded by the hospital and is thus not available for evaluation.However, there is no evidence at this time to suggest the ipg had been malfunctioning prior to the impella procedure and subsequent explant.

• 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 (Section G): 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: 50073623
• Report Number: 3012563838-2026-00031
• Device Sequence Number: 18708281
• 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: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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: 11/03/2022
• Device Model Number: CCM X10
• Device Catalogue Number: 10-B411-3-XX
• Device Lot Number: H4552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Impella Heart Pump.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male