MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; Recorder, event, implantable cardiac, (without arrhythmia detection)

Model Number	DM3500
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient's insertable cardiac monitor was unable to send a remote transmission due to unspecified out of range parameters.In the following days, another transmission was successfully sent and parameters showed within normal limits.No additional intervention was performed.The patient was stable.

• 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: 24205567
• Report Number: 2017865-2026-01679
• Device Sequence Number: 13179702
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: (01)05415067027320(10)P000207728(17)260201
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K163407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2026
• Device Model Number: DM3500
• Device Lot Number: P000207728
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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
• Patient Sex: Unknown