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

Model Number	CD1311-36Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/18/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further investigation will not be required as the device has not been returned.
Event or Problem Description
It was reported that the patient had deceased due to an unknown cause.No additional information was reported.Infection was also noted.
Additional Manufacturer Narrative
Correction: b2 death date was missing.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, d1, d4, d6a and h4.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15139527
• Report Number: 2017865-2022-16491
• Device Sequence Number: 12093000
• Product Code: NVZ
• UDI-Device Identifier: 05414734506113
• UDI-Public: 05414734506113
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2022
• 2 Devices were Involved in the Event: 1 2

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: 03/31/2014
• Device Model Number: CD1311-36Q
• Device Catalogue Number: CD1311-36Q
• Device Lot Number: 3811825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/02/2022; 08/02/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 08/02/2022; 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 68 YR
• Patient Sex: Female