MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD2411-36Q

Device Problems Failure to Deliver Shock/Stimulation (1133); Failure to Convert Rhythm (1540); Low impedance (2285)

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

Event Date 01/07/2023

Event Type  Injury  

Event Description

Related manufacturer reference numbers: 2017865-2023-24289.It was reported that the patient presented in clinic for a follow-up.Upon interrogation, it was found that the implantable cardioverter defibrillator (icd) and right ventricular (rv) lead had failed to deliver a high voltage therapy with low defibrillation impedance exhibited, and noise was present on the rv lead.It was also noted that the patient had fallen and had hip surgery around that time.The icd was explanted and replaced, and programming changes were made for the rv lead.The patient was in stable condition pre, during, and post procedure.

Manufacturer Narrative

The reported events of low impedance, failure to deliver shock, and failure to convert rhythm were confirmed in the device image by tech services but was not due to a device anomaly.The device behaved as programmed.The device was above elective replacement indicator (eri) when received.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The anomaly observed in the field could not be reproduced.

• Brand Name: ELLIPSE DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 17240216
• MDR Text Key: 318219543
• Report Number: 2017865-2023-24850
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507615
• UDI-Public: 05414734507615
• 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,Followup
• Report Date: 12/06/2023

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: 06/30/2020
• Device Model Number: CD2411-36Q
• Device Catalogue Number: CD2411-36Q
• Device Lot Number: A000060261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 09/14/2023; 11/13/2023
• Supplement Dates FDA Received: 09/14/2023; 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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: TENDRIL SDX
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 82 KG