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

Model Number CD1377-36C

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported that during preparation prior to the implant procedure, the device was found to have previously been programmed for use during another previous procedure.The device was not used during the previous procedure due to the device being taken from the shelf by mistake as another type of device was intended for the previous procedure.The device was reprogrammed to original settings.During the implant procedure, sensing anomalies on the discrimination channel and loss of right ventricular sensing were noted on the device.The physician suspected the previous procedure was performed on (b)(6) 2022, however, analysis of the session records by abbott technical support indicated the device was either previously prepared on (b)(6) 2022 or the wrong date was entered on the programmer.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of a sensing anomaly was confirmed.The cause of the sensing anomaly was due to an insufficient internal supply voltage.The cause of the insufficient internal supply voltage was found to be due to a hybrid anomaly.

• Brand Name: ELLIPSE VR 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: 15521915
• MDR Text Key: 301680987
• Report Number: 2017865-2022-39881
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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,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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CD1377-36C
• Device Lot Number: A000118637
• 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: 09/09/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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