Evia DR-T 359529Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Evia DR-T pacemaker is a permanent implanted device that paces the heart. Its 92 reports, with 49 injuries and 2 deaths, often describe battery problems and early battery-replacement warnings, and some describe infection or erosion of the pocket the device sits in. One report describes pacing stopping during removal. 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
- 93
- Deaths reported
- 2
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 04035479101312), received between Mar 26, 2018 and Sep 15, 2026 — classified as 2 deaths, 50 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (14 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem48
- Battery Problem14
- Premature Elective Replacement Indicator10
- Failure to Interrogate7
- Premature End-of-Life Indicator4
- Migration or Expulsion of Device3
- Communication or Transmission Problem1
- Device Displays Incorrect Message1
Patient problems
- Unspecified Infection39
- No Clinical Signs, Symptoms or Conditions22
- No Known Impact Or Consequence To Patient17
- Pocket Erosion6
- Implant Pain3
- Discomfort2
- Death1
- Dizziness1
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
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 50772966 ↗InjuryMay 1, 2026No Pacing
DEVICE WAS AT ERI, PROGRAMMED VOO 80, LEAD CHECK OFF, AND POLARITY BIPOLAR IN PREPARATION FOR CHANGEOUT. DURING THE CHANGEOUT PROCEDURE, THE DEVICE STOPPED PACING WHEN REMOVED FROM THE POCKET. DEVICE WAS EXPLANTED AND REINTERROGATED AFTER THE PROCEDURE AND CONFIRMED TO NOT HAVE BEEN IN BACKUP MODE AND THAT POLARITIES WERE STILL SET TO BIPOLAR. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25059517 ↗MalfunctionApr 17, 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 24916033 ↗InjuryApr 13, 2026Premature Elective Replacement Indicator; Failure to Transmit Record
DEVICE EXPLANTED DUE TO ERI INDICATION WITH UNEXPECTED BATTERY BEHAVIOR. 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 24864463 ↗InjuryJan 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 24002591 ↗InjuryNov 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 23518549 ↗InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO DEVICE POCKET WAS BEGINNING TO SHOW SIGNS OF EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 22388983 ↗MalfunctionMar 14, 2025Failure to Interrogate; Failure to Interrogate
CLINICIAN WAS UNABLE TO INTERROGATE DEVICE. DEVICE REMAINS IMPLANTED AT THIS TIME. 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 21605559 ↗DeathOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT PASSED BETWEEN THE NIGHT OF (B)(6) 2023 AND MORNING OF (B)(6) 2023. THE FOLLOWING PHYSICIAN IS ASKING FOR BIOTRONIK TO ANALYZE THE DEVICE AND MAKE SURE IT WAS WORKING CORRECTLY. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 17940082 ↗InjuryMay 20, 2022Adverse 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 14462159 ↗InjuryMay 14, 2022Adverse 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 14402949 ↗MalfunctionApr 7, 2022Failure to Interrogate; Failure to Interrogate
PATIENT EXPERIENCED EPISODES OF SYNCOPE WHILE TRAVELING. DURING FOLLOW UP THE DEVICE WAS NOT ABLE TO BE INTERROGATED. DEVICE WAS REPLACED.
Patient problems: Syncope/Fainting
MAUDE report 14047593 ↗MalfunctionFeb 14, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
AFTER AN IMPLANTATION PERIOD OF APPROX. 79 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE ERI STATUS. THE PATIENT ADMITTED FOR URGENT DEVICE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13524611 ↗InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO LEAD VEGETATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 13472099 ↗MalfunctionJan 17, 2022Extracardiac stimulation; Extracardiac stimulation
PATIENT REPORTS DISCOMFORT AT IMPLANT SITE (ABDOMINAL) WHEN HE CAN TELL DEVICE IS PACING. TESTING IN OFFICE SUGGESTS POCKET STIMULATION DUE TO UNIPOLAR PACING AND HIGH OUTPUT, AS WELL AS PATIENT DISCOMFORT WITH PACING. OUTPUT WAS LOWERED AND RATE RESPONSE TURNED OFF TO REDUCE UNNECESSARY PACING PER PHYSICIAN. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Discomfort
MAUDE report 13268642 ↗MalfunctionJan 6, 2022Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED. HOME MONITORING SHOWED THE BATTERY AT 25 PERCENT THE SAME DAY. THE 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 13180208 ↗MalfunctionJan 6, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE HIT ERI ON SEPT 3 2021 BUT IN MAY WAS AT ABOUT 50 PERCENT. 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 13177710 ↗MalfunctionDec 22, 2021Failure to Interrogate; Failure to Interrogate
DEVICE IS UNABLE TO BE INTERROGATED. PATIENT WAS LOST TO FOLLOW UP FOR SEVERAL YEARS AND IS NOT FOLLOWED ON HOME MONITORING. DEVICE CURRENTLY REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13060651 ↗MalfunctionNov 23, 2021No Device Output; No Device Output
DEVICE EXPLANTED DUE TO THE PATIENT EXPERIENCING DIZZINESS AND THE GENERATOR HAVING NO OUTPUT. IT WAS DECIDED TO REMOVED BOTH THE DEVICE AND RV LEAD AS THE PATIENT IS PACEMAKER DEPENDENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Dizziness
MAUDE report 12863740 ↗MalfunctionNov 22, 2021Battery Problem; Battery Problem
IT WAS REPORTED THAT A BATTERY ERROR MESSAGE WAS DISPLAYED WHEN THE PATIENT VISITED TO THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12858217 ↗InjuryNov 12, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
DEVICE EXPLANTED DUE TO POCKET PAIN AND MIGRATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Implant Pain
MAUDE report 12804842 ↗MalfunctionNov 11, 2021Failure to Interrogate; Failure to Interrogate
THIS DEVICE WAS UNABLE TO BE INTERROGATED. 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 12796175 ↗MalfunctionNov 9, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO SUDDEN ERI. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12781426 ↗MalfunctionNov 3, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED FOR EOL. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12747133 ↗InjuryNov 3, 2021Adverse 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, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 12747126 ↗
Other Pulse generator, permanent, implantable devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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