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

Model Number	DM5000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pocket Erosion (2013); Discomfort (2330)
Date of Event	07/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was reported that the patient presented to the clinic with mild protrusion of the insertable cardiac monitor (icm).The icm was repositioned on (b)(6) 2026.Following the reposition procedure, the patient reported a sensation that the device was protruding from the implant site and applied a bandage over the area.The patient later reported that the device was no longer noticeable by the following morning.The patient remained in stable condition.

• Brand Name: Assert-IQ¿ ICM
• 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: 50693075
• Report Number: 2017865-2026-19025
• Device Sequence Number: 13175260
• Product Code: MXC
• UDI-Device Identifier: 05415067047793
• UDI-Public: (01)05415067047793(10)P000244871(17)270520
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K230286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: DM5000
• Device Lot Number: P000244871
• 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: 08/20/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2025
• 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: Male