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

Model Number	CD1311-36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	02/11/2019
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 developed an infection.The patient presented on (b)(6) 2019 for procedure and the system was explanted.The patient was stable post procedure.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.
Additional Manufacturer Narrative
Correction: (b)(4).
Event or Problem Description
New information received on (b)(4) 2019 indicated that the patient also experienced erosion.

• 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: 8368083
• Report Number: 2017865-2019-02864
• Device Sequence Number: 1620186
• Product Code: NVZ
• UDI-Device Identifier: 05414734506106
• UDI-Public: 05414734506106
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 04/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2013
• Device Model Number: CD1311-36
• Device Lot Number: 3692945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/18/2019; 03/18/2019; 04/16/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 03/18/2019; 03/18/2019; 04/19/2019
• 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
• Patient Age: 43 YR
• Patient Weight: 60