Sentus ProMRI OTW QP S-85/49 406082Recalls & 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 heart pacing lead is a wire placed in the heart to help control its rhythm, and its 505 reports mostly describe the lead moving out of position. Some report fractures, failure to pace, and infections around the device. There is 1 death and 110 injuries reported, and no recalls name this device. Reports fell to 32 in the past year from 55 in the year before.
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
- 511
- Deaths reported
- 1
- Injuries reported
- 115
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 511 adverse event reports that list this exact device (DI 04035479145606), received between Jun 15, 2018 and Sep 25, 2026 — classified as 1 death, 115 injuries, 395 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (298 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 Dislocated298
- Adverse Event Without Identified Device or Use Problem88
- Failure to Capture50
- High impedance35
- Fracture30
- Ambient Noise Problem23
- High Capture Threshold19
- Over-Sensing14
Patient problems
- No Clinical Signs, Symptoms or Conditions284
- No Known Impact Or Consequence To Patient117
- Unspecified Infection67
- Undesired Nerve Stimulation14
- Twiddlers Syndrome7
- Muscle Stimulation6
- Pocket Erosion6
- Vascular Dissection4
Recent adverse event reports
The 25 most recent of 511 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903028 ↗InjurySep 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 50899520 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Undesired Nerve Stimulation
MAUDE report 50874723 ↗InjurySep 8, 2026Ambient Noise Problem
This lead was capped due to 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 50669906 ↗MalfunctionSep 3, 2026Failure to Capture; Fracture; Ambient Noise Problem; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590297 ↗InjurySep 1, 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 50552160 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infection. Should additional information become available, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50550243 ↗InjuryAug 26, 2026Fracture
This lead was explanted due to fracture from patient twiddling. Should additional information be received this file will be updated.
Patient problems: Twiddlers Syndrome
MAUDE report 50457257 ↗InjuryMay 19, 2026Positioning Problem
POSITION OF LEAD WAS NOT PROVIDING ADEQUATE CRT SYNCHRONIZATION. DUE TO LENGTH OF IMPLANT AND THE PATIENTS AGE, MD ELECTED TO CAP RATHER THAN ATTEMPT EXTRACTION. NO ADVERSE PATIENT EVENTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216363 ↗InjuryMay 12, 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 25149426 ↗InjuryMay 8, 2026Break
INSULATION BREACH AT THE PIN DURING GENERATOR CHANGE. LV LEAD WAS TURNED OFF AT THIS TIME AND REMAINS IMPLANTED. 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 25123733 ↗InjuryApr 27, 2026Break
THIS LEAD WAS CAPPED DUE TO ENTIRE PIN OF LEAD BROKE OFF DURING GEN CHANGE. INSULATION WAS PULLED BACK AND WIRES WERE EXPOSED. 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 25010216 ↗InjuryApr 20, 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 24923394 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO POCKET EROSION/INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 24859158 ↗InjuryMar 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 24706949 ↗InjuryMar 2, 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 24482778 ↗InjuryFeb 24, 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 24429076 ↗MalfunctionFeb 20, 2026High impedance; Ambient Noise Problem
OUT OF RANGE LV PACING IMPEDANCE (GREATER THAN 3000 OHMS) SEEN ON HOME MONITORING. SENSING WAS PROGRAMMED OFF PREVIOUSLY DUE TO NOISE ON THE LV CHANNEL. LEAD TO BE EVALUATED FURTHER AND REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400174 ↗InjuryFeb 17, 2026Adverse 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 24365049 ↗InjuryFeb 9, 2026Fracture; High impedance
LEAD WAS SHOWING FLUCTUATING HIGH IMPEDANCE. THE POCKET WAS OPENED TO RULE OUT HEADER ISSUE AND THE LEAD WAS FOUND TO BE FRACTURED UNDER THE SUTURE SLEEVE. LEAD STILL FUNCTIONAL IN POLE 1 AND 3. WE MOVED SUTURE SLEEVE AND ADDED A LEAD REPAIR KIT OVER FRACTURED PORTION. LEAD REMAINS IMPLANTED AND ACTIVE. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292432 ↗InjuryFeb 9, 2026Device Dislodged or Dislocated; Migration
THIS LEAD WAS EXPLANTED DUE TO DISLODGEMENT SECONDARY TO DEVICE POCKET MIGRATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24291063 ↗InjuryFeb 3, 2026Device 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 24246045 ↗InjuryJan 27, 2026Failure to Capture; High impedance
THIS LEAD WAS CAPPED DUE TO LOSS OF CAPTURE AND PACING IMPEDANCE OUT OF RANGE. 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 24190612 ↗InjuryJan 23, 2026Device 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 24161269 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 24125453 ↗
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
- ATTAIN® BIPOLAR OTW 419478Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode5 deaths464 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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