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

Model Number	CD2275-36
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During an in clinic follow-up, premature battery depletion was noted on the device.The device was explanted and replaced to resolve the event and the patient was in stable condition.
Additional Manufacturer Narrative
The reported field event of premature battery depletion was confirmed in the lab.The cause of the early battery depletion was due to high current draw from the device.The source of high input current was revealed to be a hybrid anomaly.Furthermore, telemetry, pacing, sensing, impedance, patient notifier, high voltage output, and high voltage shock were tested on the bench and no anomaly was observed.

• Brand Name: ELLIPSE DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10785434
• Report Number: 2938836-2020-08963
• Device Sequence Number: 19559309
• Product Code: NVZ
• UDI-Device Identifier: 05414734505901
• UDI-Public: 05414734505901
• 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
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 09/30/2019
• Device Model Number: CD2275-36
• Device Catalogue Number: CD2275-36
• Device Lot Number: 6510356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/23/2020
• 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: Required Intervention