MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD1311-36
Medical Device Problem Codes	Over-Sensing (1438); Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	05/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient presented in the emergency room after experiencing syncope due to ventricular fibrillation (vt).It was noted that the implantable cardioverter defibrillator exhibited undersensing during vt and therapy was not provided.Oversensing episodes were also noted on the device.The patient was treated with medication and no programming changes were made.
Event or Problem Description
New information states that the device was explanted on (b)(6) 2019 for an upgrade to biv.The patient was stable.
Additional Manufacturer Narrative
The reported field event was not confirmed in the laboratory.Device was tested on the bench and no anomalies were found.

• 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 Key: 7605686
• Report Number: 2017865-2018-08835
• Device Sequence Number: 16550078
• Product Code: NVZ
• UDI-Device Identifier: 05414734506106
• UDI-Public: 05414734506106
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: CD1311-36
• Device Lot Number: 3700532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 03/04/2019; 07/23/2019
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 03/12/2019; 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention