Edora 8 DR-T 407145Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Edora 8 DR-T pacemaker is an implanted heart-rhythm device. Most of its 977 reports mention infection, and many describe the device being removed, along with pocket erosion, early battery warnings and discomfort. The reports mention 10 deaths and 841 injuries. No recalls name this device, and reports in the last 12 months fell to 64 from 104 in the previous 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
- 982
- Deaths reported
- 10
- Injuries reported
- 844
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 982 adverse event reports that list this exact device (DI 04035479147648), received between Jun 7, 2018 and Sep 30, 2026 — classified as 10 deaths, 844 injuries, 128 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (31 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 Problem832
- Premature Elective Replacement Indicator31
- Failure to Interrogate23
- Failure to Capture17
- Battery Problem13
- High impedance9
- Pacing Problem9
- Migration or Expulsion of Device8
Patient problems
- Unspecified Infection682
- No Clinical Signs, Symptoms or Conditions108
- Pocket Erosion75
- Implant Pain30
- No Known Impact Or Consequence To Patient20
- Discomfort17
- Endocarditis15
- Bacteremia12
Recent adverse event reports
The 25 most recent of 982 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
This device was explanted due to epidural abscess, aortic valve endocarditis and staph bacteremia. Should additional information be received this file will be updated.
Patient problems: Abscess; Bacteremia; Endocarditis
MAUDE report 50949866 ↗MalfunctionSep 25, 2026Premature Elective Replacement Indicator; Battery Problem
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 50899329 ↗MalfunctionSep 23, 2026No Pacing
Patient problems: Syncope/Fainting
MAUDE report 50874726 ↗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 50787238 ↗InjurySep 15, 2026Adverse 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 50772967 ↗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 50735004 ↗InjuryJul 6, 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 25727645 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO BACTEREMIA. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia
MAUDE report 25669922 ↗InjuryJun 29, 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 25652585 ↗InjuryJun 9, 2026Battery Problem
AN IN-CLINIC FOLLOW-UP ON (B)(6) 2025 INDICATED 45 PERCENT BATTERY REMAINING, WITH A CALCULATED ERI OF 4 YEARS, 0 MONTHS. HOWEVER, ERI WAS DETECTED ON (B)(6) 2026. THE PATIENT UNDERWENT AN MRI ON (B)(6), 2026. IT IS RECOMMENDED TO MANAGE THE DEVICE AS ERI. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25444500 ↗InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. PATIENT AND FOLLOWING PHYSICIAN COULD NOT PROVIDE EXACT EXPLANT DATE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25435170 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED DUE TO IT WAS CAUSING DISCOMFORT. A POCKET REVISION WAS ATTEMPTED, BUT PHYSICIAN CHOSE TO PUT IN A NEW BATTERY SINCE CURRENT BATTERY WAS 3 YEARS OLD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 25385664 ↗InjuryMay 21, 2026Premature Elective Replacement Indicator; Battery Problem
THIS DEVICE WAS EXPLANTED DUE TO ERI WITH UNEXPECTED BATTERY BEHAVIOR. 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 25245062 ↗InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS FEELING DISCOMFORT ON LATERAL SIDE. PHYSICIAN DECIDED TO MOVE THE DEVICE MORE MEDIAL. DEVICE REPOSITIONED AND REMAINS IMPLANTED.
Patient problems: Discomfort
MAUDE report 25210787 ↗InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD SKIN INFECTION THAT TUNNELED TO THE POCKET AND TO THE DEVICE; ENTIRE SYSTEM WAS EXTRACTED.
Patient problems: Skin Infection
MAUDE report 25107274 ↗InjuryApr 27, 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 25000521 ↗MalfunctionApr 21, 2026Failure to Interrogate
DEVICE COULD NOT BE INTERROGATED. PATIENT REPORTED GETTING AN X-RAY LAST WEEK. DEVICE 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 24941690 ↗InjuryApr 20, 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 24932917 ↗MalfunctionApr 15, 2026Premature Elective Replacement Indicator
THE DEVICE WAS INTERROGATED A FEW DAYS AGO AND DISPLAYED APPROXIMATELY 60 PERCENT BATTERY REMAINING. UPON INTERROGATION (B)(6) 2026, THE DEVICE NOW DISPLAYS AN ERI BATTERY STATUS. UNKNOWN IF PATIENT HAD ANY RECENT MEDICAL PROCEDURES THAT CORRELATE WITH THE ERI STATUS. IT IS RECOMMENDED THAT THE DEVICE BE MANAGED AS ERI. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24888136 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 24887833 ↗InjuryApr 14, 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 24876896 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT HAD COMPLAINTS OF POCKET DISCOMFORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 24872194 ↗MalfunctionApr 9, 2026Premature Elective Replacement Indicator
THIS 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 24829938 ↗InjuryApr 8, 2026No Pacing
DURING A GENERATOR CHANGE, THE PATIENT WAS PROGRAMMED TO D00 MODE AT 70 BPM WITH LEAD CHECK SET TO OFF. AFTER THE DEVICE WAS REMOVED FROM THE POCKET, A COMPLETE LOSS OF PACING WAS OBSERVED. THE RV LEAD WAS DISCONNECTED FROM THE DEVICE HEADER AND CONNECTED TO A NEW PM, THEN PLACED INTO THE POCKET, AT WHICH POINT PACING RESUMED. THE PHYSICIAN DOES NOT BELIEVE BOVIE CAUTERY MADE CONTACT WITH THE DEVICE. NO OTHER 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 24822869 ↗InjuryApr 8, 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 24822371 ↗
Other Pulse generator, permanent, implantable devices
- Assurity™ PM2240St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall84 deaths4,076 reports
- 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
- Zephyr™ XL DRSt. Jude Medical, Inc. · Pulse generator, permanent, implantable24 deaths944 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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