MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 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 04/03/2024

Event Type  Injury  

Event Description

It was reported that the insertable cardiac monitor (icm) exhibited bluetooth telemetry loss.The patient then presented in clinic for follow-up.Upon interrogation, it was found that the icm exhibited failure to be interrogated via induction as well.The icm was explanted and replaced.Patient condition was stable.

• 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: 19120141
• MDR Text Key: 340337826
• Report Number: 2017865-2024-38557
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067040046
• UDI-Public: (01)05415067040046(10)P000157308(17)240503
• 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: Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2024
• Device Model Number: DM4500
• Device Lot Number: P000157308
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2022
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female