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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3257-40Q
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 06/14/2019
Type of Reportable Event Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event or Problem Description
It was reported that the patient expired.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death is unknown.Related manufacturer reference number: 2017865-2019-16935, 017865-2019-16936.
 
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
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Brand Name
UNIFY ASSURA ICD
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key9365428
Report Number2017865-2019-16934
Device Sequence Number16951786
Product Code NIK
UDI-Device Identifier05414734505635
UDI-Public05414734505635
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P030035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date (Section B) 02/10/2020
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
Operator of Device Health Professional
Device Expiration Date07/31/2014
Device Model NumberCD3257-40Q
Device Catalogue NumberCD3257-40Q
Device Lot Number3941257
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 11/05/2019
Supplement Date Received by Manufacturer02/07/2020
Initial Report FDA Received Date11/22/2019
Supplement Report FDA Received Date02/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
DURATA STS OPTIM ACTIVE FIXATION; TENDRIL ST
Outcome Attributed to Adverse Event Death;
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