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TILDA T 60Recalls & reported problems

BIOTRONIK SE & Co. KG · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035479143350), received between Jul 16, 2018 and Jul 16, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Capture” (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

Device problems

  • Failure to Capture1
  • High impedance1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 16, 2018Failure to Capture; High impedance; Failure to Capture; High impedance

    IT WAS REPORTED THIS LEAD WAS REPLACED DUE TO HIGH IMPEDANCE AND LOSS OF CAPTURE. THE LEAD WAS CAPPED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7690630 ↗

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Sources and updates

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