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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSERT-IQ¿ ICM; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION) Back to Search Results
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.
 
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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 Key17667433
MDR Text Key322525527
Report Number2017865-2023-39066
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05415067047816
UDI-Public05415067047816
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K230286
Number of Events Reported1
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 NumberDM5300
Device Lot NumberS000091180
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 Received08/31/2023
Supplement Dates Manufacturer Received09/27/2023
04/25/2024
Supplement Dates FDA Received10/13/2023
05/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age76 YR
Patient SexMale
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