Sentus ProMRI OTW QP S-75/49 406081Recalls & 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 OTW QP S-75/49 is a drug-eluting wire lead for the heart's left ventricle, implanted to help the heart beat. The 55 reports mostly describe the lead moving out of position inside the vein, along with leads that stop pacing the heart correctly, break apart, or show high impedance. Some leads were removed because of infection or unwanted nerve and muscle sensations. 14 reports describe injuries and no deaths were reported. No recalls name this device, and no reports were filed in the past 12 months.
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
- 55
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 04035479145590), received between Jun 15, 2018 and Aug 4, 2025 — classified as 14 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (34 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 Dislocated34
- Adverse Event Without Identified Device or Use Problem7
- Failure to Capture7
- Fracture4
- High impedance3
- Ambient Noise Problem2
- Break1
- Device Sensing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Known Impact Or Consequence To Patient17
- Unspecified Infection7
- Muscle Stimulation2
- Undesired Nerve Stimulation2
- Discomfort1
- Shock from Patient Lead(s)1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22704291 ↗MalfunctionMay 28, 2025Device Dislodged or Dislocated; Device 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 22095553 ↗MalfunctionApr 24, 2025Device Dislodged or Dislocated; Device 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 21905522 ↗MalfunctionOct 16, 2024Break; Break
LV LEAD BODY SEPARATED FROM LEAD PIN WHEN DISCONNECTING LEAD FROM EXISTING GENERATOR DURING GEN CHANGE PROCEDURE. NO ADVERSE PATIENT EVENTS REPORTED. LEAD WAS CAPPED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20460865 ↗InjurySep 4, 2024Adverse 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 20141636 ↗MalfunctionAug 8, 2024Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance
LV LEAD EXTRACTED DUE TO LEAD FRACTURE. ALSO >3000OHM IMPEDANCE DETECTED WITH LOSS OF CAPTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19945165 ↗MalfunctionJun 18, 2024Failure to Capture; Failure to Capture
THIS LV LEAD WAS CAPPED DUE TO NON-CAPTURE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19557634 ↗MalfunctionMar 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD WAS EXPLANTED BECAUSE IT DISLODGED INTO SVC. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921682 ↗MalfunctionJan 25, 2024Fracture; High impedance; Fracture; High impedance
THIS LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCE AND FRACTURE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18580006 ↗MalfunctionNov 21, 2023Device 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 18182181 ↗MalfunctionSep 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
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 17816818 ↗MalfunctionJul 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS CAPPED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17424332 ↗MalfunctionJul 25, 2023Fracture; Fracture
THIS LEAD WAS EXPLANTED DUE TO POSSIBLE FRACTURE. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17393952 ↗InjuryJul 14, 2023Positioning Problem; Positioning Problem
THIS LV LEAD WAS CAPPED DUE TO PT WAS NOT IMPROVING WITH PLACEMENT IN BRANCH OF ANTERIOR INTRAVENTRICULAR VEIN AND NEW LV LEAD WAS PLACED IN CS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17326880 ↗MalfunctionMay 1, 2023Device 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 16850851 ↗MalfunctionJan 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LV LEAD WAS EXPLANTED DUE TO DISLODGEMENT. 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 16235582 ↗MalfunctionDec 12, 2022High impedance; High impedance
LEAD WAS EXPLANTED DUE TO IMPEDANCE ABOVE 3009OHMS. 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 15959512 ↗InjuryDec 8, 2022Adverse 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 15946229 ↗MalfunctionOct 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LEAD WAS EXPLANTED ON (B)(6) 2022 DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15610848 ↗MalfunctionOct 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THIS LV LEAD WAS EXPLANTED DUE TO DISLODGEMENT INTO THE RV. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15531564 ↗MalfunctionOct 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD DISLODGED 4 DAYS AFTER IMPLANT AND WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15528095 ↗InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 15451795 ↗MalfunctionMay 13, 2022Fracture; Fracture
LV LEAD EXPLANTED AND REPLACED 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 14395942 ↗MalfunctionOct 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD EXPLANTED DUE TO DISLODGEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12561564 ↗MalfunctionJul 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
LEAD DISLODGED WHILE TRYING TO EXPLANT RV LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12229243 ↗
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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