MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE VR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD1411-36Q

Device Problem Failure to Convert Rhythm (1540)

Patient Problem Arrhythmia (1721)

Event Date 10/09/2023

Event Type  Injury  

Event Description

It was reported that a patient was in ventricular tachycardia, the implantable cardioverter defibrillator (icd) delivered shocks but was unable to convert the rhythm.Emergency medical services (ems) arrived and converted the rhythm with external defibrillation.No changes or interventions were reported.The patient is stable in the intensive care unit.

Manufacturer Narrative

A device history record (dhr) review was performed and was found complete.

• Brand Name: ELLIPSE VR
• 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: 18024401
• MDR Text Key: 326760805
• Report Number: 2017865-2023-50894
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507738
• UDI-Public: 05414734507738
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: CD1411-36Q
• Device Lot Number: A000044964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 01/16/2024; 04/22/2024
• Supplement Dates FDA Received: 01/16/2024; 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2017
• 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: DURATA RV LEAD
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male