MAUDE Adverse Event Report: ABBOTT ELLIPSE DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2377-36C

Device Problems Over-Sensing (1438); No Pacing (3268)

Patient Problems Arrhythmia (1721); Dizziness (2194)

Event Date 03/04/2023

Event Type  Injury  

Event Description

It was reported that p-wave oversensing resulting in pacing inhibition was reported on the device.As a result the patient experienced cardiac pauses and dizziness.The device was explanted and replaced to resolve the event and the patient was in stable condition.

Manufacturer Narrative

The reported field events of p-wave oversensing resulting in pacing inhibition issue were not confirmed.A visual inspection of the septum, setscrew and contact spring revealed no anomalies that could contribute to the reported event.The telemetry, impedance, sensing, pacing and high voltage output functions of the device were tested and observed to be normal.

• Brand Name: ELLIPSE DR ICD, US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16636593
• MDR Text Key: 312225276
• Report Number: 2017865-2023-16126
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: CD2377-36C
• Device Lot Number: A000063887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2018
• 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
• Patient Outcome(s): Required Intervention