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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY ASSURA CRT-D RF HV; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD3357-40C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2020
Event Type  Death  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
It was reported the patient passed away.The primary cause of death was listed as cardiac arrest.It was unknown if the implantable cardioverter defibrillator had any role in this event.The patient was deceased.
 
Manufacturer Narrative
Analysis was normal.No device problem found.
 
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Brand Name
UNIFY ASSURA CRT-D RF HV
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10962628
MDR Text Key220102489
Report Number2017865-2020-21898
Device Sequence Number1
Product Code NIK
UDI-Device Identifier05414734508186
UDI-Public05414734508186
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,Followup
Report Date 01/27/2021
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
Device Operator Health Professional
Device Expiration Date02/28/2018
Device Model NumberCD3357-40C
Device Catalogue NumberCD3357-40C
Device Lot NumberA000018361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received12/07/2020
Supplement Dates Manufacturer Received01/27/2021
Supplement Dates FDA Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age93 YR
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