Sentus ProMRI OTW QP L-85/49 408719Recalls & 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 pacemaker lead is a wire that carries signals between a pacemaker and the left side of the heart. Many of the 1,374 reports describe the lead moving out of position, high electrical resistance or the heart not being reliably stimulated, and some mention leads removed after making the diaphragm contract. The reports include 7 deaths, 501 injuries and 866 malfunctions. 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
- 1,385
- Deaths reported
- 7
- Injuries reported
- 510
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,385 adverse event reports that list this exact device (DI 04035479148959), received between Dec 19, 2017 and Sep 29, 2026 — classified as 7 deaths, 510 injuries, 868 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (468 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 Dislocated468
- Adverse Event Without Identified Device or Use Problem410
- High impedance205
- Failure to Capture182
- Ambient Noise Problem140
- Fracture108
- High Capture Threshold51
- Extracardiac stimulation43
Patient problems
- No Clinical Signs, Symptoms or Conditions698
- Unspecified Infection327
- No Known Impact Or Consequence To Patient173
- Undesired Nerve Stimulation75
- Twiddlers Syndrome31
- Muscle Stimulation20
- Pocket Erosion20
- Bacteremia11
Recent adverse event reports
The 25 most recent of 1,385 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Device Dislodged or Dislocated
Patient problems: Twiddlers Syndrome
MAUDE report 50940803 ↗InjurySep 29, 2026High Capture Threshold
This LV lead was capped due to high thresholds. 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 50933057 ↗InjurySep 29, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926840 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50926786 ↗InjurySep 25, 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 50899792 ↗InjurySep 25, 2026Extracardiac stimulation; High Capture Threshold
The LV lead was explanted due to high threshold and phrenic nerve stim. Should additional information be received this file will be updated.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50899159 ↗InjurySep 25, 2026Malposition of Device
Lead was capped due to sub-optimal position. 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 50896828 ↗InjurySep 24, 2026Failure to Capture; Device Dislodged or Dislocated
This LV lead was explanted due to dislodgement resulting in failure to capture. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50886521 ↗InjurySep 23, 2026Device Dislodged or Dislocated
This lead was explanted, same day as implant, due to dislodgement. Should additional information become available, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870680 ↗InjurySep 23, 2026Fracture; High impedance
This lead was explanted due to Impedances greater than 3000 ohms, possibly due to a lead fracture. 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 50870618 ↗InjurySep 16, 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 50787337 ↗InjurySep 11, 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 50734838 ↗MalfunctionSep 11, 2026Ambient Noise Problem
Possible lead noise on LV lead. No adverse patient events were reported. Device currently remains implanted. Should additional information be received, this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734420 ↗InjurySep 9, 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 50692328 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50615321 ↗InjurySep 3, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50599385 ↗MalfunctionSep 2, 2026Intermittent Capture; Ambient Noise Problem; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569490 ↗InjurySep 2, 2026High impedance; Extracardiac stimulation; High Capture Threshold
This lead was explanted due to high threshold, high impedance, and diaphragm stim. Should additional information be received this file will be updated.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50565559 ↗InjuryAug 31, 2026Break
This LV lead broke after tug test during device changeout and IS4 pin remained in ICD. Lead was cut and capped. 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 50530983 ↗InjuryAug 31, 2026Failure to Capture; Extracardiac stimulation
This lead was explanted due to no capture and diaphragmatic stimulation. No adverse patient events were reported. Should additional information become available, this file will be updated.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50530849 ↗InjuryAug 26, 2026Failure to Capture; High impedance; Malposition of Device
This LV lead had impedance of 3000 on all poles and no capture. Upon opening the pocket, the lead was found to be bent at a severe angle coming out of the LV port. The pocket was enlarged to allow the lead to lay in a straighter position 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 50456373 ↗InjuryAug 19, 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 50333036 ↗InjuryAug 19, 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 50331026 ↗InjuryAug 17, 2026Unstable Capture Threshold
This lead was explanted due to the phrenic nerve stimulation and threshold was very near the capture threshold. Should additional information become available, this file will be updated.
Patient problems: Undesired Nerve Stimulation
MAUDE report 50284561 ↗InjuryAug 13, 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 50241247 ↗
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
- 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
- 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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