MAUDE Adverse Event Report: ABBOTT MEDICAL (CRM-SYLMAR) JOT DX¿ ICM; Recorder, event, implantable cardiac, (without arrhythmia detection)

Model Number	DM4500
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for a device check.Device interrogation indicated that the implantable cardiac monitor (icm) exhibited electromagnetic interference (emi) oversensing.No changes or intervention were reported.The patient condition was not known.

• Brand Name: JOT DX¿ 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: 25648795
• Report Number: 2017865-2026-13352
• Device Sequence Number: 20299821
• Product Code: MXC
• UDI-Device Identifier: 05415067040046
• UDI-Public: (01)05415067040046(10)P000242861(17)270422
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K163407
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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 Model Number: DM4500
• Device Lot Number: P000242861
• 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: 06/11/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2025
• 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
• Patient Age: 78 YR
• Patient Sex: Female