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TILDA R 60Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 3 · Implant

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04035479143312), received between Dec 18, 2019 and Oct 6, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3
  • Insufficient Device Problem Information1

Patient problems

  • Unspecified Infection2
  • No Known Impact Or Consequence To Patient1
  • Pocket Erosion1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    LIVANOVA PROVIDED THE FOLLOWING INFORMATION: ON (B)(6) 2020, EROSION OF THE SUBJECT DEVICE AND ASSOCIATED OSCOR LEADS WAS REPORTED AND THEY WERE SUBSEQUENTLY EXPLANTED THE FOLLOWING DAY.

    Patient problems: Pocket Erosion

    MAUDE report 10639145 ↗
  • 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 10563052 ↗
  • 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 10145922 ↗
  • MalfunctionDec 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    LIVANOVA/MICROPORT PROVIDED THE FOLLOWING INFORMATION: THE PATIENT REGISTRATION FORM INDICATES THAT THE LEAD WAS REPLACED DUE TO A LEAD PROBLEM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9489226 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.