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

Model Number CD1275-36Q

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Hypoxia (1918); Neurological Deficit/Dysfunction (1982)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined. .

Event Description

The patient experienced ventricular fibrillation (vf).Therapy was delivered but was not successful in terminating the vf.The patient received external defibrillation which finally terminated the arrhythmia.Due to the length of the episode, the patient suffered cerebral consequences due to hypoxia.The patient was sent to the intensive care unit (icu) and is on a respirator.There is no allegation of malfunction against the device.Additional information has been requested and not yet received.

Event Description

Additional information was received indicating the device was functioning as programmed and there was no alleged malfunction of the device.Furthermore, the device was unable to terminate the ventricular fibrillation due to patient condition.

• Brand Name: ELLIPSE VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8693441
• MDR Text Key: 147806241
• Report Number: 2938836-2019-04648
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734506038
• UDI-Public: 05414734506038
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

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: 02/28/2019
• Device Model Number: CD1275-36Q
• Device Lot Number: S000039869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/12/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2017
• 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): Hospitalization; Required Intervention