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

Model Number CD1411-36C

Device Problems Failure to Deliver Shock/Stimulation (1133); Low impedance (2285); Charging Problem (2892)

Patient Problem Arrhythmia (1721)

Event Date 08/20/2022

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2022-21974.It was reported that a patient reported to the emergency room with an implantable cardioverter defibrillator exhibiting a loss of defibrillation therapy.Attempted shocks had failed due to low defibrillation impedance on the right ventricular lead.This resulted in a over current detection (ocd) alert.The patient arrhythmia was resolved through external defibrillation.Diagnostic imaging found no anomalies.Programming changes were made, and the lead was successfully capped on (b)(6) 2022 and replaced.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported event of high voltage lead impedance, high voltage output anomaly, and charging issue was confirmed.The cause of the low high voltage lead impedance, high voltage output anomaly, and charging issue was due to over current detection (ocd).Interrogation of the device revealed 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 cause of the ocd experienced by the field could not be determined.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15364219
• MDR Text Key: 299317049
• Report Number: 2017865-2022-22454
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507707
• UDI-Public: 05414734507707
• 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: 10/05/2022

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: 03/31/2017
• Device Model Number: CD1411-36C
• Device Catalogue Number: CD1411-36C
• Device Lot Number: A000002895
• 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: 08/22/2022
• Initial Date FDA Received: 09/06/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male