Sentus ProMRI OTW QP S-75 401179Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04035479138400), received between Dec 9, 2019 and Nov 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2020Failure to Capture; High impedance; Failure to Capture; High impedance

  HIGH IMPEDANCE AND A LOSS OF CAPTURE WAS OBSERVED ON THIS LEFT VENTRICULAR LEAD AFTER THE PATIENT RECEIVED AN APPROPRIATE SHOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10778981 ↗
• MalfunctionDec 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  APPROXIMATELY 6 MONTHS AFTER IMPLANTATION LEAD DISLODGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9440321 ↗