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

Model Number DM5300

Device Problems Over-Sensing (1438); Under-Sensing (1661)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented remotely via merlin.Net.The transmission revealed that the patient¿s implantable cardiac monitor (icm) recorded multiple false atrial fibrillation (af) episodes due to oversensing and false pause episodes due to undersensing.The clinic will continue to monitor the patient.No intervention was performed.The patient was in stable condition.

Manufacturer Narrative

The reported event of false af episodes were confirmed.Based on the information provided, the af discrimination algorithms in the device inhibited some false detections, but had false af episodes triggered due to lack of repeatable pattern in r-r intervals, baseline noise, and inconsistent p-wave morphology.The device was performing per design.

Event Description

New information received notes the patient's implantable cardiac monitor (icm) had false pause episodes due to under-sensing.No intervention performed and patient consequences were reported.

• Brand Name: ASSERT-IQ¿ 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: 17667433
• MDR Text Key: 322525527
• Report Number: 2017865-2023-39066
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067047816
• UDI-Public: 05415067047816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230286
• 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: 05/20/2024

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
• Device Operator: Health Professional
• Device Model Number: DM5300
• Device Lot Number: S000091180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/27/2023; 04/25/2024
• Supplement Dates FDA Received: 10/13/2023; 05/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2023
• 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 Age: 76 YR
• Patient Sex: Male