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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pocket Erosion (2013)
Event Date 01/09/2024
Event Type  Injury  
Event Description
It was reported that the patients implantable cardiac monitor (icm) fell out of the pocket.The icm was not replaced, and the patient will be monitored.The patient was in stable condition.
 
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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 Key18569420
MDR Text Key333548588
Report Number2017865-2024-01886
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 Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 01/24/2024
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? No
Device Operator Health Professional
Device Model NumberDM5300
Device Lot NumberS000091411
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/09/2024
Initial Date FDA Received01/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2023
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 Outcome(s) Required Intervention;
Patient Age92 YR
Patient SexMale
Patient Weight78 KG
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