Sentus ProMRI OTW QP L-75 401182Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04035479138431), received between May 22, 2019 and Jun 27, 2022 — classified as 1 death, 7 malfunctions.

The most frequently reported specific device problem is “High impedance” (4 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2022Fracture; Fracture

  PARTIAL LV LEAD FRACTURE WAS REPORTED. CARDIAC DEVICE REPROGRAMMING AND LV LEAD REPLACEMENT ATTEMPT WERE DONE. THE LEAD REPLACEMENT FAILED SO THIS LEAD REMAINS IMPLANTED AT THIS TIME. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837190 ↗
• MalfunctionMay 7, 2022Positioning Failure; Positioning Failure

  THIS LV LEAD WAS EXPLANTED AND REPLACED DUE TO REPORTED SUBOPTIMAL LV LEAD POSITION. DURING THE REPLACEMENT, A NEW LV LEAD WAS NEEDED, IT WAS OTHER CURVE, TO CANNULATE THE CORRECT POSITION. THE PATIENT WAS HOSPITALIZED. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14324162 ↗
• DeathMar 1, 2022Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT ABNORMAL SHOCK IMPEDANCE AND RV IMPEDANCE WERE SEEN IN HOME MONITORING. ARRHYTHMIA WAS NOT DETECTED. THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT DIED BETWEEN (B)(6) 2021. THE GENERAL PRACTITIONER HAS NO FURTHER INFORMATION REGARDING THE CAUSE OF DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13637983 ↗
• MalfunctionJun 23, 2021Failure to Capture; High impedance; Failure to Sense; Failure to Capture; High impedance; Failure to Sense

  IT WAS REPORTED THAT AFTER RECENT DEVICE CHANGE, THERE IS NO SENSING ON LV AND NO CAPTURE ON ALL LV LEADS. IMPEDANCE ALL LEADS GREATER THAN 3000 OHMS. THE LEAD IS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049356 ↗
• MalfunctionMay 13, 2021Fracture; Fracture

  AFTER AN IMPLANTATION PERIOD OF APPROX. 57 MONTHS, A LEAD FRACTURE WAS OBSERVED BY HOMEMONITORING. THE LEAD WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11819571 ↗
• MalfunctionNov 20, 2020Failure to Capture; High impedance; Ambient Noise Problem; Failure to Capture; High impedance; Ambient Noise Problem

  LV LEAD DID NOT CAPTURE, IMPEDANCE WAS HIGHER THAN 3000 OHMS AND NOISE WAS PRESENT ON IEGM CHANNEL. THE PATIENT WAS HOSPITALIZED AND THE LV LEAD REPLACED. BOTH THE LV LEAD AND DEVICE HAVE BEEN SUBSTITUTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10878085 ↗
• MalfunctionAug 28, 2020Failure to Capture; High impedance; Failure to Capture; High impedance

  LV LEAD WITH LOSS OF CAPTURE ON ALL POLES WITH UNCHANGED POSITION. SINCE (B)(6) OF 2019 THE IMPEDANCE HAS BEEN GREATER THAN 3000 OHM. THE REVISION WAS THEN SUCCESSFULLY PERFORMED ON (B)(6) 2020.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10466480 ↗
• MalfunctionMay 22, 2019High impedance; High impedance

  APPROXIMATELY 45 MONTHS AFTER IMPLANTATION, HOME MONITORING SYSTEM REPORTED IMPEDANCE GREATER THAN 3000 OHMS ON LV LEAD. LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633061 ↗