MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) JOT DX¿ ICM; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)

Model Number DM4500

Device Problems Signal Artifact/Noise (1036); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Incorrect Interpretation of Signal (1543)

Patient Problems Pocket Erosion (2013); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  Injury  

Event Description

It was reported that the patient exhibited difficulty in pairing their insertable cardiac monitor (icm) to the merlin app.Upon further investigation, it was found that the icm exhibited loss of bluetooth telemetry functionality.No changes were reported.There were no patient consequences.

Event Description

New information received notes an x-ray showed the insertable cardiac monitor (icm) had migrated.There was a communication loss and the last transmission showed artifact, inappropriately labeled as pause.There were no patient consequences.

Event Description

New information received notes fluoroscopy was performed and the device was unable to be located.New information received indicated the patient removed the device on their own and it was lost.There were no patient consequences.

• Brand Name: JOT DX¿ ICM
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18415700
• MDR Text Key: 331603869
• Report Number: 2017865-2023-95796
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067040046
• UDI-Public: 05415067040046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM4500
• Device Lot Number: P000173916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Male