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

Model Number CD1377-36QC

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559)

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

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

Implant date is estimated to have occurred in 2020.

Event Description

During follow-up, increased pacing impedance, loss of capture and loss of sensing were noted on the device.The event was resolved by explanting and replacing the device.The patient was in stable condition.

Manufacturer Narrative

The reported event high pacing impedance was not confirmed in the lab.The measured pacing impedance values were within the normal measurement ranges.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.

Manufacturer Narrative

The reported event high pacing impedance, loss of sensing, and loss of capture was not confirmed in the lab.The measured pacing impedance values were within the normal measurement ranges.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.

• 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: 13176047
• MDR Text Key: 283306349
• Report Number: 2017865-2022-00331
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2022

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: 12/31/2021
• Device Model Number: CD1377-36QC
• Device Lot Number: S000074578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 02/18/2022; 04/05/2022
• Supplement Dates FDA Received: 02/24/2022; 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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