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	Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient implanted with an osm ipg experienced sudden cardiac death and was successfully revived by their concomitant icd.However, the patient's ejection fraction became reduced and their pre-ccm heart failure symptoms returned.Medications were added and ef improved as did hf symptoms, but not back to peak.The patient decided they wanted both leads on (v1 lead had previously been turned off by physician due to patient sensations) for maximum ccm benefit.During the lead revision, it was noted that v2 sensing had fallen, so that lead was replaced.The physician then decided to also upgrade the patient's ccm device from the implanted os to a new osm ipg.The explanted os ipg was decontaminated at an approved decontamination facility before being returned to impulse dynamics usa.There is no evidence to indicate the os ipg was malfunctioning at the time of explant, and the device was ultimately scrapped.

• 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: 50258172
• Report Number: 3012563838-2026-00057
• Device Sequence Number: 13227261
• 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: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/09/2026

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: 04/24/2024
• Device Model Number: CCM X10
• Device Catalogue Number: 10-B411-3-XX
• Device Lot Number: H4810
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2024
• 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
• Date Device Manufactured: 03/11/2022
• 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