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); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that implantable cardioverter defibrillator exhibited far field oversensing and noise that was oversensed by the device.Both sensing anomalies were unable to be reproduced in clinic.The physician alleged the source of the noise was an issue inside the header.The device was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of atrial far field over sensing and ventricular noise were confirmed by analysis.Final analysis found the sensing and noise were caused by external (non-device related) factors.The reported event of header anomaly was not confirmed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.During analysis, a failure event was observed which was unrelated to the reported event.Final analysis found the battery depleted prematurely.Interrogation revealed the device was at elective replacement indicator (eri) when received.A longevity calculation was performed and found the battery depletion was premature based on the device usage.No high current drain sources were found.The battery analysis by the manufacturer found the battery was normal.The cause of premature battery depletion could not be determined.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12037465
• Report Number: 2017865-2021-23675
• Device Sequence Number: 19827320
• Product Code: NVZ
• UDI-Device Identifier: 05414734505987
• UDI-Public: 05414734505987
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 04/30/2015
• Device Model Number: CD2311-36
• Device Catalogue Number: CD2311-36
• Device Lot Number: 4320037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male