Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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)
Type of Reportable Event Death
Event or Problem Description
Related manufacturer reference number: 2017865-2020-00138.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.
 
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9552813
Report Number2017865-2020-00137
Device Sequence Number1953784
Product Code NVZ
UDI-Device Identifier05414734506106
UDI-Public05414734506106
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/21/2020
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 Number3759507
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2019
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/17/2019
Supplement Date Received by Manufacturer02/19/2020
Initial Report FDA Received Date01/06/2020
Supplement Report FDA Received Date02/21/2020
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
RIATA ACTIVE FIXATION
Outcome Attributed to Adverse Event Death;
-
-