TILDA T 53Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04035479143343), received between Jul 11, 2019 and Jul 2, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Ambient Noise 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2020Fracture; High impedance; Ambient Noise Problem; Fracture; High impedance; Ambient Noise Problem

  LIVANOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: THE PATIENT IS AN (B)(6)-YEAR-OLD GENTLEMAN, WHO HAS A HISTORY OF CHRONIC ATRIAL FIBRILLATION, COMPLETE HEART BLOCK AND A DUAL-CHAMBER PACEMAKER IN PLACE. HE IS PACEMAKER DEPENDENT AND HAS SHOWN EVIDENCE OF FRACTURE ON HIS RV LEAD WITH LEAD IMPEDANCE GREATER THAN 3000 OHMS AND EVIDENCE OF NOISE LEADING TO INHIBITION OF THE PACING. HIS CURRENT DEVICE SWITCHES TO UNIPOLAR WITH THE INCREASED IMPEDANCE AS A RESULT. OUR PLAN IS TO PLACE A TEMPORARY WIRE FOLLOWED BY A NEW RV LEAD PLACEMENT AND REPLACEMENT OF PULSE GENERATOR.

  Patient problems: Atrial Fibrillation; Complete Heart Block

  MAUDE report 10224945 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIVANOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: SYSTEM EXPLANT DUE TO INFECTION. PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 8781204 ↗