Estella DR-T 371207Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04035479114299), received between Jan 10, 2020 and Nov 2, 2021 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2021Failure to Interrogate; Premature End-of-Life Indicator; No Pacing; Failure to Interrogate; Premature End-of-Life Indicator; No Pacing

  DEVICE WAS EXPLANTED DUE TO EOS. PATIENT LOST TO FOLLOW-UP AND DEVICE WAS NO LONGER PACING OR ABLE TO BE INTERROGATED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741043 ↗
• DeathJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS BEING EXPLANTED DUE TO EROSION. PATIENT HAD COMPLETE HEART BLOCK AND A VERY SLOW HEART RATE. THE PACEMAKER WAS EXPLANTED AND CONNECTED VIA TEMP LEAD. IT WAS PACING THROUGH THE PROCEDURE UP UNTIL THE PATIENT PASSED. THE ORIGINAL POCKET WAS CLOSED BY THE PHYSICIAN A COUPLE MINUTES PRIOR TO TIME OF DEATH. THE RA LEAD WAS EXTRACTED BUT PHYSICIAN WAS UNSUCCESSFUL IN EXTRACTING RV LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Pocket Erosion

  MAUDE report 12120906 ↗
• MalfunctionJun 15, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS DEVICE SHOWED A BATTERY ERROR UPON INTERROGATION. DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. THE MANUFACTURER ANALYSIS REVEALED A BATTERY ISSUE. NO ADVERSE PATIENT EVENTS WERE REPORTED, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12002698 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS IMPLANTED (B)(6) 2021. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 11272825 ↗
• InjuryJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE IS CURRENTLY NO INDICATION THAT A NEW SYSTEM HAS BEEN IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

  Patient problems: Unspecified Infection

  MAUDE report 9574549 ↗