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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 Failure to Interrogate (1332); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2019
Event Type  malfunction  
Event Description
It was reported that before the implant procedure, the device was attempted to interrogate.Upon interrogation, the implantable cardiac monitor delivered an error message.The device was not used.A new device was implanted successfully without any complications.
 
Manufacturer Narrative
Analysis was normal.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
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
8184932577
MDR Report Key8308822
MDR Text Key135143209
Report Number2017865-2019-01788
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05415067027320
UDI-Public05415067027320
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/29/2019
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberS000061596
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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