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

Model Number DM4500

Device Problem Failure to Interrogate (1332)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that during a follow up in clinic, the device was unable to be interrogated.No intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.

• Brand Name: JOT DX¿ ICM
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 19023324
• MDR Text Key: 339156751
• Report Number: 2017865-2024-37487
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067040046
• UDI-Public: (01)05415067040046(10)S000090204(17)241012
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM4500
• Device Lot Number: S000090204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1