Tendril™ SDX (REF 1688T-85)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734005777), received between Dec 30, 2019 and Nov 3, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Capturing Problem” (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

Recent adverse event reports

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

• MalfunctionNov 3, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW-UP. UPON INTERROGATION, IT WAS FOUND THAT THE PATIENT'S PACEMAKER AND RIGHT VENTRICULAR LEAD EXHIBITED NOISE. EPISODES OF NOISE REVERSION WERE NOTED. IT WAS ALSO NOTED THAT THE PACEMAKER EXHIBITED OVER-SENSING OF THE NOISE. PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12746360 ↗
• InjuryJun 22, 2020Fracture; Capturing Problem; Fracture; Capturing Problem

  IT WAS REPORTED THAT DURING A GENERATOR UPGRADE ON (B)(6) 2020, WHEN THE RV LEAD THRESHOLDS WERE CHECKED, THE THRESHOLDS WERE VERY POOR, AND THE RV LEAD WAS FRACTURED. THE RIGHT ATRIAL LEAD WAS EXAMINED, AND THE LEAD IMPEDANCE WAS VERY HIGH AND WAS BELIEVED THAT THE LEAD WAS FRACTURED. THE RV LEAD AND ATRIAL LEAD WERE EXPLANTED AND REPLACED. THE LV LEAD WAS CAPPED DUE TO DYSFUNCTIONAL. THE PATIENT CONDITION WAS STABLE. RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-07019 AND 2938836-2020-07020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10182263 ↗
• MalfunctionDec 30, 2019Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN EMERGENCY ROOM, COMPLETE HEART BLOCK WITH LOSS OF CAPTURE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD CAPTURE THRESHOLD HAD GRADUALLY RISEN OVER TIME AND EVENTUALLY REACHED ABOVE THE MAXIMUM OUTPUT. PROGRAMMING CHANGE WAS MADE, AND IT WAS ABLE TO GET THE RV CAPTURE. THE DEVICE WAS TURNED OFF WITH NO MALFUNCTION. THE LEADLESS PACEMAKER WAS IMPLANTED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9531402 ↗