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	Bacterial Infection (1735)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a patient implanted with an optimizer smart (os) implantable pulse generator (ipg) had their device explanted due to a "localized infection".The explant had occurred in a hospital while the patient was in another state approximately 1,500 miles from their home.The hospital reported that the patient's concomitant crt-d was infected: "the defibrillator is infected, leading to endocarditis from the device." the hospital reported the patient had a streptococcal infection that resulted in "cardiac vegetation." both of the patient's cardiac implants, the crt-d and os ipg, were explanted, and the patient was put on a 6-week course of antibiotics after the procedure.The patient is expected to receive replacement devices after they complete their course of antibiotics.However, a replacement procedure for either device has not yet been scheduled.The disposition of the explanted os ipg is currently unknown but there is no evidence at this time to suggest the os ipg caused or contributed to the infection.A review of the ohr and sterilization documentation for this device was conducted, and no anomalies were found.The explanted device and additional details are currently being sought from the hospital where the explant was performed.
Event or Problem Description
This is an amendment to a previously filed mdr.On march 4, 2025, it was confirmed that the device had been scrapped by the hospital after explant.Therefore, a full product evaluation of the device will not be possible.There remains no evidence to suggest the os ipg implanted three years prior caused or contributed to the patient's infection that developed around their crt-d device.

• 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 ; 8564347921
• MDR Report Key: 20091339
• Report Number: 3012563838-2024-00030
• Device Sequence Number: 7764645
• 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: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 06/01/2023
• Device Model Number: CCM X10
• Device Catalogue Number: 10-B401-3-XX
• Device Lot Number: H4680
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 03/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ABBOT ST JUDE QUADRA ASSURA MP CRT-D
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male