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

Model Number CD1411-36Q

Device Problems Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959)

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

Event Type  malfunction  

Event Description

It was reported that patient presented in clinic for routine follow-up.Upon interrogation, it was found that patient's implantable cardioverter defibrillator (icd) was in backup mode due to firmware update related reset.It was further noted that device was not able to interrogate.The device was able to reset to normal setting by programming intervention.The patient status was unknown.

• 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: 19159985
• MDR Text Key: 340814052
• Report Number: 2017865-2024-39312
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507738
• UDI-Public: (01)05414734507738(10)A000020742(17)180430
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/22/2024

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: 04/30/2018
• Device Model Number: CD1411-36Q
• Device Lot Number: A000020742
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2016
• 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.
• Patient Age: 79 YR
• Patient Sex: Male