MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)

Model Number	DM3500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was returned.The interrogation results were normal and the visual screen was acceptable.
Event or Problem Description
It was reported that the patient presented with symptoms of skin discomfort caused by the implantable cardiac monitor (icm).The icm was explanted.There were no patient consequences.
Additional Manufacturer Narrative
Correction: section d6b - the correct " date of explant" should have been (b)(6) 2025.
Additional Manufacturer Narrative
Correction: section b1 ¿ type of report "product problem" checkbox should not be checked.

• Brand Name: CONFIRM
• Common Device Name: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24288529
• Report Number: 2017865-2026-02681
• Device Sequence Number: 21413608
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: (01)05415067027320(10)P000187708(17)250530
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K163407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2025
• Device Model Number: DM3500
• Device Lot Number: P000187708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 02/10/2026; 02/11/2026
• Initial Report FDA Received Date: 02/08/2026
• Supplement Report FDA Received Date: 02/10/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2023
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 116 KG