Sentus ProMRI OTW QP L-75/49 408718Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Sentus ProMRI is a pacemaker lead placed in the left side of the heart. Many of the 134 reports describe the lead moving out of place, infections, and the lead failing to pace the heart, and some describe the lead breaking or being removed. There are no deaths and 55 injuries, and reports rose from 7 in the previous 12 months to 17 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 135
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 135 adverse event reports that list this exact device (DI 04035479148942), received between Jun 18, 2018 and Sep 3, 2026 — classified as 56 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (55 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated55
- Adverse Event Without Identified Device or Use Problem40
- Failure to Capture17
- High impedance12
- High Capture Threshold9
- Fracture6
- Ambient Noise Problem3
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Unspecified Infection33
- No Known Impact Or Consequence To Patient21
- Pocket Erosion3
- Twiddlers Syndrome3
- Cardiac Perforation2
- Fall2
- Muscle Stimulation2
Recent adverse event reports
The 25 most recent of 135 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to Vegetation noted in Echocardiogram of RV lead. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50590296 ↗InjuryAug 26, 2026Break
Lead was capped due to it broke. 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 50456529 ↗InjuryAug 25, 2026Device Dislodged or Dislocated
This lead was explanted due to dislodgement. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50438156 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50234036 ↗InjuryAug 13, 2026Device Dislodged or Dislocated
This LV lead was explanted due to dislodgement. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230300 ↗InjuryJul 6, 2026High impedance
THIS LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE. 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 25719533 ↗InjuryMay 22, 2026Failure to Capture; Device Dislodged or Dislocated
THIS LEAD WAS CAPPED ON (B)(6) 2026 DUE TO DISLODGEMENT RESULTING IN NON-CAPTURE OF ALL LV VECTORS. 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 25255054 ↗InjuryApr 28, 2026Fracture
THIS LEAD WAS CAPPED DUE TO FRACTURE. 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 25023720 ↗InjuryMar 30, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24719402 ↗InjuryFeb 26, 2026Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24464069 ↗InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24462502 ↗InjuryFeb 24, 2026Failure to Capture; Device Sensing Problem
THIS LV LEAD WAS CAPPED DUE TO LOSS OF SENSING/CAPTURE (STEADY DECLINE OVER 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 24429075 ↗InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem
DURING IMPLANT ATTEMPT THIS LEAD DISSECTED THE CS. IMPLANT CONTINUED WITH A NEW LEAD IN A DIFFERENT LOCATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Vascular Dissection
MAUDE report 24299888 ↗InjuryJan 26, 2026Device Dislodged or Dislocated
THIS LV LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24181336 ↗InjuryJan 19, 2026Failure to Capture
THIS LEAD WAS EXPLANTED DUE TO NO CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108755 ↗MalfunctionDec 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23935960 ↗MalfunctionDec 22, 2025Failure to Capture; Failure to Capture
THIS LV LEAD WAS EXPLANTED DUE TO FAILURE TO CAPTURE IN ANY VECTOR. 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 23873534 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 23658246 ↗InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22364605 ↗MalfunctionJun 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22128549 ↗MalfunctionMay 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22095551 ↗MalfunctionMay 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD WAS EXPLANTED BECAUSE IT DISLODGED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035875 ↗MalfunctionMar 14, 2025Break; Break
DURING DEVICE CHANGE OUT, THIS LEAD WAS CAPPED DUE TO IT BROKE APART AT THE CONNECTOR PIN. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605605 ↗InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21327351 ↗MalfunctionJan 21, 2025High impedance; High impedance
THIS LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21203739 ↗
Other Drug eluting permanent left ventricular (lv) pacemaker electrode devices
- Attain Stability™ Quad MRI SureScan™ 479888Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode28 deaths2,213 reports
- Attain Performa™ Straight MRI SureScan™ 439888Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode26 deaths1,595 reports
- Sentus ProMRI OTW QP L-85/49 408719BIOTRONIK SE & Co. KG · Drug eluting permanent left ventricular (lv) pacemaker electrode7 deaths1,385 reports
- Quartet™ 1457Q-86St. Jude Medical, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode21 deaths1,061 reports
- Quickflex™ 1258TSt. Jude Medical, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode26 deaths996 reports
- ATTAIN® BIPOLAR OTW 419488Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode15 deaths730 reports
- Attain Ability® Plus 429688Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode11 deaths529 reports
- Sentus ProMRI OTW QP S-85/49 406082BIOTRONIK SE & Co. KG · Drug eluting permanent left ventricular (lv) pacemaker electrode1 death511 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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