Sentus ProMRI OTW QP L-95 401184Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035479138455), received between Jul 29, 2022 and Jul 29, 2022 — classified as 1 malfunction.

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

• MalfunctionJul 29, 2022Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  LEAD DISLODGEMENT WAS REPORTED. AT THE POST IMPLANT FOLLOW-UP, THE LV LEAD DID NOT CAPTURE IN ANY CONFIGURATION. RV LEAD PARAMETERS WERE REGULAR AND STABLE. AT THE X RAY THE LV LEAD TIP WAS IN ATRIUM. THE PATIENT DOES NOT APPEAR TO HAVE DONE ANYTHING THAT MAY HAVE CAUSED THE DISLODGMENT. PLANNING LV LEAD REVISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127384 ↗