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

Model Number	CD1275-36Q
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Codes	Hypoxia (1918); Neurological Deficit/Dysfunction (1982)
Date of Event	05/27/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 8693441
• Report Number: 2938836-2019-04648
• Device Sequence Number: 16732794
• Product Code: NVZ
• UDI-Device Identifier: 05414734506038
• UDI-Public: 05414734506038
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: CD1275-36Q
• Device Lot Number: S000039869
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention