Edora 8 HF-T QP 407137Recalls & 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 is an implanted pacemaker that also resynchronizes the heart. Its 98 adverse event reports include 1 death, 84 injuries and 13 malfunctions. The reports mostly describe infections and erosion that led to the device being removed, and some describe the battery reaching replacement status early. 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
- 98
- Deaths reported
- 1
- Injuries reported
- 84
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 04035479147563), received between Sep 25, 2018 and Sep 16, 2026 — classified as 1 death, 84 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (11 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 Problem83
- Premature Elective Replacement Indicator11
- Battery Problem1
- Failure to Capture1
- High Capture Threshold1
- Impedance Problem1
- Obstruction of Flow1
- Pacemaker Found in Back-Up Mode1
Patient problems
- Unspecified Infection67
- No Clinical Signs, Symptoms or Conditions12
- Pocket Erosion12
- No Known Impact Or Consequence To Patient4
- Implant Pain3
- Bacteremia2
- Pleural Effusion2
- Heart Failure/Congestive Heart Failure1
Recent adverse event reports
The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.
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 50787747 ↗InjuryAug 13, 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 50234040 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO STAPH BACTEREMIA INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia
MAUDE report 24701014 ↗InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 24185025 ↗InjuryJan 20, 2026Battery Problem
HMSC REPORTED ERI DETECTED ON (B)(6) 2026. BATTERY REPORTED AS 35 PERCENT ON (B)(6) 2026. NURSE ALSO REPORTED BATTERY WAS 2 YEARS REMAINING DURING OFFICE FOLLOW-UP IN (B)(6) 2025. NO CURRENT REPORTED PROCEDURES. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115401 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINT OF PAIN. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 23863009 ↗InjuryDec 12, 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 23788835 ↗InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 23454617 ↗InjuryOct 21, 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 23347657 ↗InjurySep 19, 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 23095503 ↗InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO POCKET EROSION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 22700121 ↗InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENTS POCKET FROM BI-V UPGRADE NEVER CLOSED COMPLETELY AND INFECTION DEVELOPED. SYSTEM WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection; Wound Dehiscence
MAUDE report 22122359 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO STAPH INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 22110819 ↗InjuryApr 23, 2025Premature Elective Replacement Indicator; Premature 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 21894430 ↗InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21687917 ↗InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO VEGETATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 21594685 ↗InjuryFeb 10, 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 21351863 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO MSSA BACTEREMIA INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Bacteremia
MAUDE report 20909460 ↗InjuryOct 29, 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 20559475 ↗InjuryOct 16, 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 20468131 ↗InjurySep 5, 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 20145127 ↗MalfunctionSep 4, 2024Failure to Capture; Premature Elective Replacement Indicator; Impedance Problem; Unexpected Mode Switch; Failure to Capture; Premature Elective Replacement Indicator; Impedance Problem; Unexpected Mode Switch
DEVICE WAS EXPLANTED DUE TO ERI. DURING THE GEN CHANGE, DEVICE WAS PROGRAMMED VOO AND TURNED OFF LEAD CHECK. DEVICE APPEARED TO GO INTO POSSIBLE BACKUP MODE. TOOK THE DEVICE OUT OF THE POCKET AND LOST CAPTURE ON DEPENDENT PATIENT. PUT THE DEVICE BACK IN POCKET AND STARTED TO CAPTURE. ATTEMPTED TO TAKE DEVICE OUT OF THE POCKET AFTER A FEW MINUTES AND DEVICE WAS CAPTURING. 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 20141683 ↗InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 20031865 ↗InjuryAug 13, 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 19976971 ↗InjuryJul 8, 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 19697187 ↗
Other Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) devices
- VALITUDE™ X4 CRT-P U128Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)2 recalls26 deaths2,073 reports
- Quadra Allure MP™ PM3562St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)26 deaths1,180 reports
- Percepta™ Quad CRT-P MRI SureScan™ W4TR01Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 recall28 deaths897 reports
- VISIONIST™ X4 CRT-P U228Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 recall4 deaths819 reports
- Percepta™ Quad CRT-P MRI SureScan™ W4TR01Medtronic, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 recall8 deaths703 reports
- INVIVE™ V173Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)1 death670 reports
- VALITUDE™ CRT-P U125Boston Scientific Corporation · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)2 recalls2 deaths558 reports
- QUADRA ALLURE MP™ PM3262St. Jude Medical, Inc. · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)27 deaths518 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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