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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 Defective Device (2588)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 10/05/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found the device to have depleted prematurely.The cause of the premature battery depletion was due to excess current on the hybrid.
 
Event or Problem Description
This report is to advise of an event observed during analysis.
 
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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 Key12615297
Report Number2017865-2021-33095
Device Sequence Number3473279
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 Year2014
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date02/28/2014
Device Model NumberCD1311-36
Device Catalogue NumberCD1311-36
Device Lot Number3793326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2020
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/05/2021
Initial Report FDA Received Date10/12/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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