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 Premature Discharge of Battery (1057); Failure to Interrogate (1332)

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

Event Date 12/28/2023

Event Type  Injury  

Event Description

It was reported that a patient presented with loss of bluetooth low energy telemetry noted on the patient's insertable cardiac monitor.No intervention or adverse patient consequences were reported.

Manufacturer Narrative

The results of the software analysis are inconclusive since relevant information related to the event was not able to be obtained.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

New information received notes that premature battery depletion was noted on the device.The device was explanted on (b)(6) 2024.No adverse consequences were reported.

• 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: 18754678
• MDR Text Key: 335966875
• Report Number: 2017865-2024-33233
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2024
• Device Model Number: DM4500
• Device Lot Number: P000158966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 05/11/2024; 08/01/2024
• Supplement Dates FDA Received: 05/11/2024; 08/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2022
• 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: 80 YR
• Patient Sex: Male