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

Model Number CD1411-36C

Device Problems Premature Discharge of Battery (1057); Under-Sensing (1661); Capturing Problem (2891)

Patient Problem Arrhythmia (1721)

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that the patient present for in-clinic follow-up after a ventricular fibrillation episode implant of a left ventricular assist device (lvad).It was observed that after lvad placement, that there was decrease in r wave sensed amplitude and increase in capture threshold was by the implantable cardioverter defibrillator.Also noted, were under-sensed of tachycardia episodes and significant unexpected battery depletion.Programming interventions were made.The patient was stable.

Manufacturer Narrative

The reported event of a decrease in longevity after the capacitor maintenance check occurred was confirmed.Based on the information provided, it was determined that the decrease in longevity was due to an increase in pacing output at the time of the longevity assessment.The software analysis found that the device is performing per design.

• Brand Name: ELLIPSE VR
• 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: 18567827
• MDR Text Key: 333539506
• Report Number: 2017865-2024-01745
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: CD1411-36C
• Device Lot Number: A000080589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2018
• 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: DURATA; LEFT VENTRICULAR ASSIST DEVICE
• Patient Sex: Female