Sentus ProMRI OTW QP L-85 401183Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 04035479138448), received between Apr 12, 2019 and Jul 29, 2022 — classified as 2 deaths, 20 injuries, 61 malfunctions.

The most frequently reported specific device problem is “High impedance” (26 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 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2022Failure to Capture; High impedance; Failure to Capture; High impedance

  THIS LEAD SHOWED STRANGE BEHAVIOR OVER THE PAST 2 MONTHS, IMPEDANCES GREATER THAN 3000 OHMS AND NON CAPTURE BETWEEN 1-2 POLE AND 2-3 POLE. THE READINGS WERE GOOD IN UNIPOLAR MODE, HOWEVER, WHEN SITTING UPRIGHT, THERE IS NO CAPTURE FROM 2 POLE-CAN (1 POLE TO-CAN NP AND 4 POLE TO-CAN THRESHOLD GREATER THAN 5V). GIVEN BEHAVIOR DECIDED TO REPLACE THE LEAD, LEAD WAS WELL IN THE HEADER AND WAS ALSO WELL FIXATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127383 ↗
• InjuryJul 11, 2022Break; Inappropriate/Inadequate Shock/Stimulation; Break; Inappropriate/Inadequate Shock/Stimulation

  FOLLOWING WAS REPORTED: ON (B)(6) 2022, LEAD FAILURE WAS OBSERVED VIA HM, AND INAPPROPRIATE SHOCKS WERE OBSERVED AS WELL. ON (B)(6) 2022, DEVICE CHECK WAS DONE, AND OBSERVED AN LV LEAD BREAK. ON (B)(6) 2022, REPLACEMENT WAS DONE AND LV LEAD WAS CAPPED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 14977537 ↗
• MalfunctionJul 5, 2022Fracture; Fracture

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 81 MONTHS IT WAS REPORTED THAT THE LEAD WAS EXTRACTED DUE TO SUSPECTED FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14919716 ↗
• MalfunctionJun 22, 2022Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS LV LEAD WAS EXPLANTED AND REPLACED DUE TO INCREASED IMPEDANCE (ABOVE 3000 OHM) AND ARTIFACTS APPROX. 4 MONTHS AFTER THE IMPLANTATION. THE X-RAY SHOWED KINK OF THE LEAD BODY. 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 14783051 ↗
• MalfunctionJun 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEAD WAS EXPLANTED DUE TO DISLODGEMENT DETECTED BY HOMEMONITORING. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14732543 ↗
• MalfunctionJun 9, 2022Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  DURING THE DEVICE CHECK AT FOLLOW UP, ABNORMAL LV LEAD IMPEDANCES WERE OBSERVED. ALSO, THE THRESHOLD WAS HIGH. THEREFORE SETTING WAS CHANGED (LV PACING SENSING POLARITY). (B)(6) 2022, THE EXPLANT OPERATION WAS STARTED. HOWEVER, WHEN ANGIO WAS TAKEN, IT WAS DECIDED THAT THERE IS NO BRANCH TO INSERT LV LEAD. THE RELEVANT LV LEAD WAS PLANNED TO BE RE-IMPLANTED WITH ANOTHER SYSTEM (BIPOLAR CRTD), AND THE OPERATION WAS STARTED. DURING THE OPERATION, THERE WAS OCCLUSION WHEN SVC ANGIO WAS DONE AND GUIDEWIRE WAS NOT ABLE TO BE INSERTED. THEREFORE, IT WAS GIVEN UP TO PROCESS FURTHER FOR THIS OPERATION. THIS LV LEAD REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14642786 ↗
• MalfunctionMay 26, 2022High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  THIS LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE AND NOISE. 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 14516000 ↗
• DeathMay 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HOSPITALIZED AFTER A FALL. THERE WAS A SUSPICION OF INFECTION. THERE WAS ALSO SKIN NECROSIS AROUND THE POCKET. THE SKIN NECROSIS WAS CLEANED. THE SYSTEM REMAINS IMPLANTED AT THIS TIME.

  Patient problems: Heart Failure/Congestive Heart Failure; Necrosis; Unspecified Infection

  MAUDE report 14407110 ↗
• MalfunctionMay 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEAD DISLODGEMENT WAS REPORTED. LEAD CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS REPORT WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336710 ↗
• MalfunctionApr 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEFT VENTRICULAR LEAD WAS DETECTED TO BE INACTIVE DURING REMOTE MONITORING. SINCE THE PATIENT HAD RECENTLY UNDERGONE CARDIOTHORACIC SURGERY (REPORTED SEPARATELY), THE PRE-DISCHARGE EXAMS WERE MORE CLOSELY OBSERVED, IN WHICH A DISPLACEMENT OF THE LEFT LEAD WAS OBSERVED. THE INVESTIGATOR ASSESSED THIS EVENT AS CAUSAL RELATED TO PATIENTS MEDICAL HISTORY. THE PATIENT WAS HOSPITALIZED. REPLACEMENT OF THE LEFT VENTRICULAR LEAD WITH REMOVAL OF THE PREVIOUS LEAD WAS DONE. CHEST X-RAY WAS DONE FOR DIAGNOSTICS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14103656 ↗
• MalfunctionApr 11, 2022Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT PACING IMPEDANCE ON THIS LV LEAD WAS OUT OF RANGE (GREATER THAN 3000 OHM) DURING THE FOLLOW-UP APPROX. 11 MONTHS AFTER THE IMPLANTATION. LEAD BREAKAGE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079443 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS DIAGNOSED WITH THE INFECTION. THE PATIENT WAS HOSPITALIZED AND EXPLANT WAS DONE.

  Patient problems: Unspecified Infection

  MAUDE report 13476972 ↗
• MalfunctionJan 31, 2022High impedance; High impedance

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 15 MONTHS IT WAS REPORTED THAT THE LEAD WAS EXTRACTED DUE TO HIGH PACING IMPEDANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13404554 ↗
• MalfunctionJan 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT SUFFERED FROM PHRENIC NERVE STIMULATION. DISLODGEMENT OF THE LV LEAD INTO THE HIGH RIGHT ATRIUM WAS DIAGNOSED. OLD LV LEAD WAS EXPLANTED AND A NEW LV LEAD WAS IMPLANTED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 13342042 ↗
• MalfunctionDec 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LV LEAD DISLODGED, IT WAS EXPLANTED. NO ADVERSE PATIENT EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967921 ↗
• MalfunctionDec 1, 2021Failure to Capture; High impedance; Failure to Capture; High impedance

  THIS LV LEAD SHOWED HIGH IMPEDANCES OF GREATER THAN 2500 OHMS AND LOSS OF CAPTURE. THE LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913938 ↗
• MalfunctionOct 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LV LEAD DISLODGED APPROX. 1 MONTH AFTER THE IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712168 ↗
• MalfunctionOct 12, 2021Impedance Problem; Impedance Problem

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 7 MONTHS, IT WAS REPORTED THAT THE LEAD WAS EXTRACTED DUE TO AN IMPEDANCE ISSUE. SENSING POLARITY WAS SWITCHED TO UNIPOLAR AUTOMATICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12619885 ↗
• MalfunctionSep 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE LV LEAD DISLODGED. THE PATIENT WAS HOSPITALIZED. THE LV LEAD WAS REPLACED AND THE PULSE GENERATOR REPROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12533034 ↗
• MalfunctionAug 31, 2021Over-Sensing; Over-Sensing

  AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 62 MONTHS, IT WAS REPORTED THAT THE LEAD WAS EXTRACTED DUE TO OVERSENSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12397852 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WOUND DEHISCENCE AND POCKET EROSION WERE REPORTED ON THIS LEAD. LEAD REMAINS IMPLANTED.

  Patient problems: Pocket Erosion; Wound Dehiscence

  MAUDE report 12388856 ↗
• MalfunctionAug 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. THE DATE OF EXPLANT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329075 ↗
• MalfunctionAug 16, 2021Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT LOSS OF CAPTURE WAS OBSERVED ON THIS LV LEAD. IT WAS EXPLANTED APPROX. 21 MONTHS AFTER THE IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329070 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUFFERED FROM A POCKET HEMATOMA AND INFECTION. THE INVESTIGATOR ASSESSED THIS EVENT AS POSSIBLE RELATED TO THE PATIENTS MEDICATION WITH WARFARIN. THE PATIENT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 12316611 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUFFERED FROM INFECTIVE ENDOCARDITIS ASSOCIATED TO CRT LEADS. VEGETATIONS WERE SEEN. THE PATIENT WAS HOSPITALIZED. CARDIOTHORACIC SURGERY WAS PERFORMED TO REMOVE VEGETATIONS. THE CRT WAS PROGRAMMED TO OFF. ANTIBIOTIC THERAPY WAS STARTED. FOR DIAGNOSTICS A TTE WAS DONE. THE DEVICE WILL BE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 12316305 ↗