MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) ELLIPSE DR ICD; Pulse generator, permanent, implantable

Model Number CD2411-36C

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Arrhythmia (1721)

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented in the emergency room (er) with symptoms of arrhythmia.It was alleged that the patient's implantable cardioverter defibrillator failed to deliver high voltage therapy to convert the rhythm.No intervention was performed.The patient's status was unknown.

• Brand Name: ELLIPSE DR ICD
• Type of Device: Pulse generator, permanent, implantable
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18069523
• MDR Text Key: 327381435
• Report Number: 3006705815-2023-07147
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507585
• UDI-Public: 05414734507585
• 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: Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/03/2023

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: 01/31/2019
• Device Model Number: CD2411-36C
• Device Lot Number: A000034353
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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.; TENDRIL.
• Patient Sex: Male