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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR Back to Search Results
Model Number DM3500
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/19/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information was requested but not received.
 
Event Description
It was reported that a patient's implantable cardiac monitor was explanted.There was no indication given as to why the device was explanted.
 
Event Description
New information notes that the reason for explant is an upgrade to a pacemaker.
 
Manufacturer Narrative
The device was tested on the bench and using automated testing equipment, and no anomalies were found.
 
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Brand Name
CONFIRM
Type of Device
IMPLANTABLE CARDIAC MONITOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10172101
MDR Text Key195702250
Report Number2017865-2020-07889
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05415067027320
UDI-Public05415067027320
Combination Product (y/n)N
PMA/PMN Number
K163407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2020
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberS000064027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Was the Report Sent to FDA? No
Date Manufacturer Received07/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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