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

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 03/02/2023

Event Type  Injury  

Event Description

It was reported that the patient presented during clinical follow-up.Upon interrogation, it was noted that the implantable cardioverter defibrillator failed to provide high voltage output due to the device not classifying ventricular tachycardia with supraventricular tachycardia correctly.Programming changes were performed.The patient was in stable condition.

• Brand Name: ELLIPSE DR
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16595594
• MDR Text Key: 311817195
• Report Number: 2017865-2023-14490
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: CD2411-36Q
• Device Catalogue Number: CD2411-36Q
• Device Lot Number: A000072222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• 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: OPTISURE MRI; TENDRIL LEAD
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male