Siello T 60Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04035479106263), received between May 9, 2019 and Apr 26, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2021High Capture Threshold; High Capture Threshold

  AFTER AN IMPLANTATION PERIOD OF APPROX. 63 MONTHS, AN INCREASING THRESHOLD WAS OBSERVED. THE LEAD WAS CAPPED AND THE PACEMAKER WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729604 ↗
• MalfunctionFeb 6, 2020Failure to Capture; High impedance; Failure to Capture; High impedance

  AFTER AN IMPLANTATION PERIOD OF APPROX. 57 MONTHS, IT WAS REPORTED THAT THERE WAS NO CAPTURE ON THE VENTRICULAR CHANNEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9676452 ↗
• MalfunctionJan 15, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THE PATIENT HAD A VERY HIGH AND FLUCTUATING VENTRICULAR THRESHOLD UPON NEW LEAD INSERTION. THE LEAD WAS REPOSITIONED WITH NO SUCCESS AND FINALLY IT WAS EXPLANTED THREE DAYS AFTER THE IMPLANTATION. A NEW LEAD WITH ACTIVE FIXATION WAS IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9593259 ↗
• MalfunctionMay 22, 2019Failure to Capture; Failure to Capture

  APPROXIMATELY 7 DAYS AFTER IMPLANTATION, A LOSS OF CAPTURE ON THE VENTRICULAR CHANNEL WAS REPORTED. THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633778 ↗
• MalfunctionMay 9, 2019High impedance; High impedance

  OUS MDR - IT WAS REPORTED THAT APPROX. 72 MONTHS AFTER THE IMPLANT THE BIPOLAR PACING IMPEDANCE WAS OUT OF RANGE (GREATER THAN 2500 OHMS). THE DEVICE SETTINGS WERE CHANGED TO UNIPOLAR. TWO WEEKS LATER THE LEAD AND THE ENTIRE PACEMAKER SYSTEM WAS EXPLANTED AND REPLACED. THE LEAD WAS DESTROYED DURING THE EXTRACTION PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8597526 ↗