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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3231-40Q
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Information (3190)
Event Date 03/29/2019
Event Type  malfunction  
Manufacturer Narrative
Failure event observed during analysis.Final analysis found a failure to communicate.The cause of the intermittent loss of communication could not be determined.
 
Event Description
This report is to advise of an event observed during analysis.
 
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Brand Name
UNIFY CRT-D
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key8497080
MDR Text Key141382058
Report Number2017865-2019-05224
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734504393
UDI-Public05414734504393
Combination Product (y/n)N
PMA/PMN Number
P030054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2012
Device Model NumberCD3231-40Q
Device Catalogue NumberCD3231-40Q
Device Lot Number3380440
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2017
Was the Report Sent to FDA? No
Date Manufacturer Received03/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2011
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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