Tilda R 45 US 382884Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04035479143299), received between Jul 11, 2019 and Apr 27, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2020Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED IN REGARD TO THIS ATRIAL LEAD THAT: THE RA LEAD WAS FOUND TO BE FRACTURED AS WELL AS DISLODGED. FRACTURE IS LIKELY DUE TO SUBCLAVIAN CRUSH. THE LEAD WAS EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10000915 ↗
• MalfunctionSep 25, 2019High impedance; High impedance

  LIVANOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: RECENT DEVICE CHECK INDICATED EVIDENCE OF DOUBLING OF THE RV PACED SENSE IMPEDANCE AS WELL AS HIGH VOLTAGE LEAD IMPEDANCE WITH NO APPARENT NOISE SENSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9117775 ↗
• 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. NO EXPLANT OR EVENT DATES WERE PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 8781207 ↗