Amvia Edge DR-T 460163Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Amvia Edge pacemaker is an implanted pulse generator that paces the heart. Of its 163 adverse event reports, 160 are injuries and 3 are malfunctions, with no deaths. Most describe infections, and many reports say the system was removed because of infection. Some mention pocket erosion. 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
- 170
- Deaths reported
- 0
- Injuries reported
- 167
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 04035479173999), received between Oct 30, 2023 and Sep 28, 2026 — classified as 167 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Ambient Noise Problem” (3 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 Problem162
- Ambient Noise Problem3
- Pacing Problem3
- Migration2
- Connection Problem1
- Pacing Asynchronously1
Patient problems
- Unspecified Infection132
- Pocket Erosion12
- No Clinical Signs, Symptoms or Conditions7
- Bacteremia4
- Endocarditis4
- Implant Pain4
- Wound Dehiscence4
- Hematoma3
Recent adverse event reports
The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to endocarditis. Should additional information be received, this file will be updated.
Patient problems: Endocarditis
MAUDE report 50915659 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
System explanted due to pocket erosion. Should additional information be received, this file will be updated.
Patient problems: Pocket Erosion
MAUDE report 50899092 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50811788 ↗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 50788815 ↗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 50788237 ↗InjurySep 16, 2026Adverse 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 50788203 ↗InjurySep 16, 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 50782736 ↗InjurySep 9, 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 50682778 ↗InjurySep 3, 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 50590288 ↗InjurySep 2, 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 50568735 ↗InjurySep 2, 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 50566089 ↗InjuryAug 26, 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 50456824 ↗InjuryAug 26, 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 50456821 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50278588 ↗InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50278580 ↗InjuryAug 17, 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 50278392 ↗InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem
System was explanted due to infected endocarditis. Should additional information be received, this file will be updated.
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50233994 ↗InjuryAug 7, 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 50179016 ↗InjuryAug 7, 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 50178708 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION ON (B)(6) 2026. THIS DEVICE WAS USED AS A TEMP/PERM OUTSIDE THE BODY UNTIL ON (B)(6) 2026 WHEN IT WAS DISCONNECTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 25696863 ↗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 25611798 ↗InjuryJun 15, 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 25512502 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION AND EROSION OF POCKET. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 25477460 ↗InjuryJun 3, 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 25376964 ↗InjuryMay 27, 2026Pacing Problem; Ambient Noise Problem
IT WAS REPORTED THAT DURING THE GENERATOR IMPLANT PROCEDURE, THE DEVICE EXHIBITED INTERMITTENT NOISE. WHILE MANUAL PRESSURE WAS APPLIED OVER THE IMPLANTED DEVICE, PACING INHIBITION WAS OBSERVED. UPON RELEASE OF THE PRESSURE, NORMAL PACING RESUMED. THE DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310491 ↗
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
- 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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