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

Model Number	CD1275-36Q
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
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
A remote transmission was received indicating low pacing impedance on the right ventricular (rv) channel.The patient was then seen in-clinic and provocative testing and fluoroscopic imaging was conducted which were both unremarkable.No intervention has been conducted at this time.The patient was stable and will continue to be monitored.
Additional Manufacturer Narrative
Upon receipt of additional information, the device should not have been submitted as a medical device report (mdr) as the device did not indicate a malfunction that caused a serious event.
Event or Problem Description
Additional information received indicating that the physician believes the cause of the event was due to the non-abbott lead.No allegation of malfunction on the abbott device.

• Brand Name: ELLIPSE VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10782036
• Report Number: 2938836-2020-09066
• Device Sequence Number: 11578697
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: CD1275-36Q
• Device Catalogue Number: CD1275-36Q
• Device Lot Number: S000069711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1