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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 03/26/2020
Event Type  Injury  
Manufacturer Narrative
The results/ method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported that the patient was experiencing pain due to their implantable cardiac monitor.The device was explanted.The patient tolerated the procedure well and there were no complications.
 
Manufacturer Narrative
Visual inspection on device did not find any anomaly that could cause the customer complaint.The device was received at normal range of operation.Analysis of device did not find any issues or anomalies.Longevity assessment was performed and device was in the normal range of operation with appropriate remaining longevity.
 
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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 Key9979786
MDR Text Key188293754
Report Number2017865-2020-04939
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
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/13/2019
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberS000060950
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2020
Was the Report Sent to FDA? No
Date Manufacturer Received06/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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