MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2311-36
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
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
It was reported that a patient presented remotely via merlin.Net.Upon interrogation, far-r wave oversensing leading to inappropriate mode switch was discovered on the patient's implantable cardioverter defibrillator.No programming changes were made.No patient symptoms reported.
Event or Problem Description
New information received notes that corrective programming changes were performed on (b)(6) 2021.

• Brand Name: ELLIPSE DR ICD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11813222
• Report Number: 2017865-2021-17736
• Device Sequence Number: 3792710
• Product Code: NVZ
• UDI-Device Identifier: 05414734505987
• UDI-Public: 05414734505987
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 07/31/2014
• Device Model Number: CD2311-36
• Device Catalogue Number: CD2311-36
• Device Lot Number: 3958786
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR