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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD1311-36
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Death (1802)
Date of Event 12/22/2018
Type of Reportable Event Death
Additional Manufacturer Narrative
The reporter is unknown.
 
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 was systolic heart failure.
 
Additional Manufacturer Narrative
The device was returned and analyzed in the lab.Analysis of the device image and review of the programmer printouts indicated that device functioned normally while implanted.The device was tested on the bench and lead impedance measurements were found to be out of range.Based on the device image, the lead impedance anomaly is believed to have happened after explant.
 
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Brand Name
ELLIPSE VR 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 Key8317967
Report Number2017865-2019-01908
Device Sequence Number1064384
Product Code NVZ
UDI-Device Identifier05414734506106
UDI-Public05414734506106
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 02/19/2020
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 Date01/31/2014
Device Model NumberCD1311-36
Device Catalogue NumberCD1311-36
Device Lot Number3756196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/24/2019
Supplement Date Received by Manufacturer02/14/2020
Initial Report FDA Received Date02/07/2019
Supplement Report FDA Received Date02/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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