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

Model Number CD1411-36Q

Device Problems Failure to Charge (1085); Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)

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

Event Date 09/15/2023

Event Type  Injury  

Event Description

It was reported that the implantable cardioverter defibrillator exhibited backup operation.It was noted that the capacitor maintenance timed out and there was an interrogation problem.It was also mentioned that the right ventricular lead exhibited failure to capture, failure to sense and high impedance due to fracture.The lead and the device were both explanted.The patient was in stable condition.

Manufacturer Narrative

The reported event of reset due to por (power-on-reset) and charge timeout were confirmed.The reported event of interrogation problem was not confirmed.Por and charge timeout were due to excessive charges and low battery voltage.The device image was reviewed by tech services and the device behaved as programmed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.A longevity calculation was performed and found the battery depletion was normal based on the device usage.

• 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: 17892491
• MDR Text Key: 325226565
• Report Number: 2017865-2023-48001
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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 Expiration Date: 03/31/2017
• Device Model Number: CD1411-36Q
• Device Lot Number: A000003839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male