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	Sepsis (2067)
Date of Event	02/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On march 4, 2025, an impulse dynamics field representative in the eu was informed of a device explant that had taken place on (b)(6) 2025.The patient's optimizer smart (os) implantable pulse generator (ipg) and attached leads were explanted due to the patient's septic condition.The ipg and leads were scrapped by the hospital and are thus unavailable for evaluation.A review of the dhr, including was conducted and no anomalies were found.There is no evidence to indicate the patient's os ipg caused or contributed to the sepsis.

• 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: robert fasciano ; 401 route 73 n; bldg 50, ste 100; marlton, NJ 08053 ; 6174359098
• MDR Report Key: 21561290
• Report Number: 3012563838-2025-00006
• Device Sequence Number: 14546384
• Product Code: QFV
• UDI-Device Identifier: 00810003380050
• UDI-Public: 00810003380050
• Combination Product (Y/N): N
• PMA/510(K) Number: P180036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2025
• Device Model Number: CCM X10
• Device Catalogue Number: 10-B401-3-XX
• Device Lot Number: H5031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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