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

Model Number CD1411-36Q

Device Problems Failure to Deliver Shock/Stimulation (1133); Under-Sensing (1661)

Patient Problems Arrhythmia (1721); Syncope/Fainting (4411)

Event Date 12/07/2022

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital after being found unresponsive.Stored episodes were reviewed and was believed the device to have undersensed and thereby failed to treat the patient¿s polymorphic fast vt.Programming changes were recommended and made.The physician stated if the patient was able to adequately recover, a dft test would be performed at a later date and the patient might be considered for extraction and reimplant of rv lead to increase ventricular sensing.There were no allegations of lead malfunction.At this time, both the device and rv lead remain in place and under observation.All future procedures and treatment plans are contingent on the patient¿s neurological and physical recovery.

• Brand Name: ELLIPSE VR
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16080948
• MDR Text Key: 306493612
• Report Number: 2017865-2022-51102
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: CD1411-36Q
• Device Catalogue Number: CD1411-36Q
• Device Lot Number: A000090552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/04/2023
• Supplement Dates FDA Received: 01/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OPTISURE
• Patient Age: 78 YR
• Patient Sex: Male