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

Model Number CD1411-36C

Device Problems Defibrillation/Stimulation Problem (1573); Impedance Problem (2950)

Patient Problems Arrhythmia (1721); Discomfort (2330)

Event Date 12/27/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-01216.It was reported that a patient presented in-clinic.Upon examination, it was noted that the patient's implantable cardioverter defibrillator was found to have exhibited an unspecified output issue, and the patient's right ventricular lead was found to have over-sensing of noise.Corrective programming changes were made, and further surgical intervention was planned.The patient was stable throughout.

Manufacturer Narrative

The reported event of high voltage output and varying high voltage impedance anomaly were not confirmed.The reported event of noise was confirmed in the device image.However, the noise was found to be due to external (non-device related) factors.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

Event Description

New information received notes that a ventricular tachycardia was noted on the patient, which led to the implantable cardioverter defibrillator (icd) and right ventricular lead being explanted and replaced on (b)(6) 2023.Abnormal defibirllation impedance was also noted on the icd.No further patient consequences were reported.

• 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: 16180335
• MDR Text Key: 307464330
• Report Number: 2017865-2023-01215
• 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,Followup
• Report Date: 02/27/2023

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: 04/30/2019
• Device Model Number: CD1411-36C
• Device Catalogue Number: CD1411-36C
• Device Lot Number: A000039467
• 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: 12/27/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 01/09/2023; 02/27/2023
• Supplement Dates FDA Received: 01/30/2023; 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2017
• 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: 34 YR
• Patient Sex: Male