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

Model Number	CD2311-36Q
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2022-22203.It was reported that patient presented in clinic for routine follow-up.Upon interrogation, it was found that patient's implantable cardioverter defibrillator longevity was overestimated by the programmer.The device was explanted prior to elective replacement indicator due to longevity overestimation.The patient was stable.
Additional Manufacturer Narrative
The reported event of overestimation was confirmed.As received, the device was above the elective replacement indicator (eri).Longevity analysis found the battery depletion to be normal.The device functioned normally during analysis with no anomalies found.The longevity overestimation was determined to be due to an estimation inaccuracy in the merlin programmer remaining longevity calculation.

• 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: 15348246
• Report Number: 2017865-2022-22202
• Device Sequence Number: 5134380
• Product Code: NVZ
• UDI-Device Identifier: 05414734505994
• UDI-Public: 05414734505994
• 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
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 10/14/2022

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: 01/31/2014
• Device Model Number: CD2311-36Q
• Device Catalogue Number: CD2311-36Q
• Device Lot Number: 3755672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 10/07/2022; 10/14/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/12/2022; 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DURATA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic