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

Model Number	DM4500
Medical Device Problem Codes	Failure to Interrogate (1332); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a remote follow-up, the device was unable to connect to the mobile transmitter via bluetooth telemetry.The patient was seen in clinic, and a magnet was applied to reactivate the bluetooth.Additionally, the implant date was reprogrammed into the device as it was missing.There was a transmission in merlin.Net that showed the device had very little battery left.However, following interrogation, the battery was nearly full.The patient was in stable condition and will continue to be monitored.
Additional Manufacturer Narrative
Further information was requested but not received.

• Brand Name: JOT DX¿ ICM
• Common Device Name: Recorder, event, implantable cardiac, (without arrhythmia detection)
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 25668890
• Report Number: 2017865-2026-13555
• Device Sequence Number: 14862438
• Product Code: MXC
• UDI-Device Identifier: 05415067040046
• UDI-Public: (01)05415067040046(10)P000244009(17)270505
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: P000244009
• Was Device Available for Evaluation?: No
• 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: 06/12/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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 Sex: Unknown