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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 Sepsis (2067)
Date of Event 07/02/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the right ventricular lead and the implantable cardioverter defibrillator was explanted because the patient developed sepsis.The patient was stable throughout the whole procedure.
 
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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 Key7690459
Report Number2017865-2018-10369
Device Sequence Number13679516
Product Code NVZ
UDI-Device Identifier05414734506106
UDI-Public05414734506106
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P910023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/07/2018
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 Date03/31/2014
Device Model NumberCD1311-36
Device Lot Number3845292
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/03/2018
Supplement Date Received by Manufacturer09/06/2018
Initial Report FDA Received Date07/16/2018
Supplement Report FDA Received Date09/07/2018
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
1570/65, (B)(4)
Outcome Attributed to Adverse Event Required Intervention;
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