MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR; Pulse generator, permanent, implantable

Model Number CD2411-36Q

Device Problems Failure to Deliver Shock/Stimulation (1133); Incorrect Interpretation of Signal (1543)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported during in clinic follow up that the implantable cardioverter defibrillator exhibited an incorrect interpretation of signal that resulted in failure to deliver shock.Programming changes were recommended but not yet completed.The patient was stable and asymptomatic.

• Brand Name: ELLIPSE DR
• Type of Device: Pulse generator, permanent, implantable
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18352339
• MDR Text Key: 330833617
• Report Number: 2017865-2023-95013
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507615
• UDI-Public: 05414734507615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/18/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: CD2411-36Q
• Device Lot Number: A000044181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MRI CONDTENDRIL; OPTISURE
• Patient Age: 75 YR
• Patient Sex: Male