MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) CONFIRM; Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)

Model Number	DM2102
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
New information received notes that patient underwent implant due to existing syncope, in-clinic follow-up and interrogation revealed the battery depletion.The device was disposed of and session records not available.
Event or Problem Description
It was reported that a patient presented with premature battery depletion noted on the patient's insertable cardiac monitor.The device was explanted and replaced on (b)(6) 2026.No adverse patient consequences were reported.

• Brand Name: CONFIRM
• Common Device Name: Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50256602
• Report Number: 2017865-2026-17097
• Device Sequence Number: 10247226
• Product Code: MXC
• UDI-Device Identifier: 05414734502573
• UDI-Public: (01)05414734502573(10)S000087579(17)230831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2026

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: 08/31/2023
• Device Model Number: DM2102
• Device Lot Number: S000087579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2022
• 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: Required Intervention
• Patient Sex: Unknown