Eluna 8 DR-T ProMRI 394969Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Eluna 8 DR-T ProMRI is an implanted pacemaker. Its 217 reports mostly describe infections that led to the whole system being removed, along with heart-lining infection and erosion of the device pocket, and some describe batteries reaching end of life early. The reports include 1 death and 170 injuries. Reports fell from 21 in the prior 12 months to 12 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
- 217
- Deaths reported
- 1
- Injuries reported
- 170
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 217 adverse event reports that list this exact device (DI 04035479131937), received between Sep 15, 2017 and Aug 11, 2026 — classified as 1 death, 170 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (18 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
- Adverse Event Without Identified Device or Use Problem165
- Premature Elective Replacement Indicator18
- Battery Problem10
- Failure to Capture10
- Premature End-of-Life Indicator4
- Failure to Interrogate3
- Communication or Transmission Problem2
- Device Sensing Problem2
Patient problems
- Unspecified Infection128
- No Clinical Signs, Symptoms or Conditions32
- No Known Impact Or Consequence To Patient15
- Endocarditis14
- Pocket Erosion12
- Pain7
- Bacteremia4
- Implant Pain3
Recent adverse event reports
The 25 most recent of 217 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2026Premature Elective Replacement Indicator; Battery Problem
This device was explanted (b)(6) 2026. Patient presented to the emergency department on (b)(6) 2026. Per follow-up data showing changed parameters, the mode switch onset criterion was changed, and the RA sensitivity was decreased. The programming count changed from 22 to 25. It was also reported the patient underwent an MRI on (b)(6) 2026, however there is not evidence that the device was properly put into MRI mode. This device reached ERI on (b)(6) 2026. Upon interrogation on (b)(6) 2026 it was reported an error message appeared. Device was explanted due to ERI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50203714 ↗InjuryJun 24, 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 25611894 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. EXACT EXPLANT DATE COULD NOT BE OBTAINED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25225176 ↗InjuryMay 5, 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 25085684 ↗MalfunctionMay 5, 2026Premature Elective Replacement Indicator
DEVICE IS AT ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. 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 25080829 ↗InjuryApr 8, 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 24822383 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAS ENDOCARDITIS, DEVICE EXPLANTED AND IS BEING USED AS SEMI PERMANENT PACEMAKER WITH NEW LEAD UNTIL INFECTION CLEARS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 24617428 ↗InjuryMar 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 24573529 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO MRSA BACTEREMIA INFECTION AND LEAD-RELATED ENDOCARDITIS IN PATIENT WITH TYPE 2 DM WITH FOOT ULCERS. DEVICE POCKET WAS CLEAN AND NEEDED NO DEBRIDEMENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia; Endocarditis
MAUDE report 24284653 ↗InjuryJan 30, 2026Failure to Capture
THIS DEVICE WAS BEING EXPLANTED AND IT FAILED TO CAPTURE WHEN REMOVED FROM THE BODY. IT HAD BEEN PROGRAMMED BIPOLAR WITH LEAD CHECK DISABLED DURING PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221035 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO BACTEREMIA. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia
MAUDE report 23694333 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS INFECTION, PATIENT HAD AN INFECTED PORT ON RIGHT SIDE OF CHEST. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 23547757 ↗InjurySep 9, 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 BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 23007422 ↗MalfunctionSep 9, 2025Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE SHOWS ERI WITH UNEXPECTED BATTERY BEHAVIOR. DEVICE REMAINS IMPLANTED. 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 22999953 ↗MalfunctionSep 8, 2025Premature Elective Replacement Indicator; Battery Problem; Unexpected Mode Switch; Premature Elective Replacement Indicator; Battery Problem; Unexpected Mode Switch
DEVICE IN BACKUP MODE. UNEXPECTED BATTERY BEHAVIOR NOTED. 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 22993414 ↗InjurySep 3, 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 BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22953576 ↗InjuryAug 29, 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 22921449 ↗InjuryAug 20, 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 22851079 ↗MalfunctionAug 18, 2025Battery Problem; Battery Problem
THIS DEVICE SHOWS UNEXPECTED BATTERY BEHAVIOR AND REMAINS IMPLANTED. 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 22827752 ↗InjuryAug 13, 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 22794235 ↗InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO POCKET PAIN. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 22699339 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION ON VALVE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22519999 ↗InjuryMay 20, 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 22057086 ↗InjuryMar 11, 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 21579569 ↗InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 21538472 ↗
Other Pulse generator, permanent, implantable devices
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- Fortify Assura™ CD2357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable63 deaths3,571 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Ellipse™ CD2411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable42 deaths1,498 reports
- Fortify Assura™ CD2357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable25 deaths1,378 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 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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