Tilda R 53 US 382889Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04035479143305), received between Nov 6, 2019 and Apr 19, 2021 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (3 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2021Over-Sensing; Over-Sensing

  REPORTEDLY, THE PATIENT HAD A HISTORY OF MINOR ATRIAL OVERSENSING THAT WAS PREVIOUSLY MANAGED BY DECREASING THE PROGRAMMED ATRIAL SENSITIVITY. HOWEVER, THE STORED EPISODES SEEN DURING THE (B)(6) 2021 INTERROGATION ARE REPORTEDLY WORSE THAN ANYTHING SEEN IN THE PAST. PROVOCATIVE TESTING WAS PERFORMED AND NOISE ON THE ATRIAL EGM WAS REPRODUCED ALONG WITH VENTRICULAR OVERSENSING WITH THE PATIENT LYING ON HER BACK WHILE TURNING HER HEAD FROM SIDE TO SIDE. THE EGM NOISE WAS NOT ABLE TO BE REPRODUCED VIA ISOMETRICS, VALSALVA, DEEP RESPIRATION OR COUGHING. THE POST-V AND POST-R REFRACTORY PERIODS WERE SET OUT TO 155MS AND THE V SENSITIVITY VALUE WAS DECREASED TO 0.8MV. FOLLOWING THESE ADJUSTMENTS, FURTHER VENTRICULAR OVERSENSING WAS UNABLE TO BE REPRODUCED AND THE IMPACT ON INAPPROPRIATE MODE SWITCH WILL BE EVALUATED OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11691219 ↗
• InjurySep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFECTION RELATIVE TO ENTIRE IMPLANTED SYSTEM WAS REPORTED. THE ENTIRE SYSTEM WAS REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 10563042 ↗
• MalfunctionSep 3, 2020Over-Sensing; Low impedance; Over-Sensing; Low impedance

  SORIN / LIVA NOVA PROVIDED THE FOLLOWING INFORMATION: IN REVIEWING AVAILABLE EPISODES WITHIN THE PROGRAMMER FILES, IT APPEARS THAT NON-PHYSIOLOGIC ATRIAL OVERSENSING IS PRESENT. IN ADDITION, HISTORICAL LEAD IMPEDANCE MEASUREMENTS APPEAR TO INTERMITTENTLY SHOW LOW DAILY VALUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10491415 ↗
• InjuryJun 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIVANOVA PROVIDED THE FOLLOWING INFORMATION: EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10145923 ↗
• MalfunctionApr 27, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED IN REGARD TO THIS RV LEAD THAT: THIS LEAD WAS FRACTURED DUE TO SUBCLAVIAN CRUSH. THE LEAD WAS EXPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10000914 ↗
• MalfunctionDec 18, 2019Over-Sensing; Ambient Noise Problem; Over-Sensing; Ambient Noise Problem

  LIVANOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: OVERSENSING AND NOISE WERE REPORTED ON THIS LEAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489023 ↗
• MalfunctionNov 6, 2019Fracture; Fracture

  RIGHT VENTRICULAR LEAD FRACTURE WAS REPORTED BY THE PHYSICIAN. THE SUBJECT LEAD WAS REPLACED AND REMAINS IN-SITU (CAPPED).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9285775 ↗