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

Model Number CD2377-36C

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017)

Patient Problem Arrhythmia (1721)

Event Date 03/18/2022

Event Type  Injury  

Event Description

During a remote follow-up, inappropriate high-voltage (hv) therapy was delivered by the device.Technical support was contacted and the right ventricular (rv) and right atrial (ra) leads were suspected to be implanted in the incorrect lead receptacles of the device.An additional surgery was performed and the leads were switched and implanted into the correct lead receptacles of the device to resolve the event.The patient was stable and will continue to be monitored.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13906154
• MDR Text Key: 288043890
• Report Number: 2017865-2022-06227
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: CD2377-36C
• Device Lot Number: A000109200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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