Etrinsa 8 DR-T 394931Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Etrinsa 8 DR-T is an implanted pacemaker pulse generator. The 49 reports mostly describe infections around the implanted device that led to its removal, along with battery problems and units that could no longer be read by a programmer. Reports include 31 injuries and no deaths. 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
- 50
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 04035479131821), received between Jul 19, 2018 and Sep 15, 2026 — classified as 31 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (9 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 Problem31
- Premature Elective Replacement Indicator9
- Battery Problem5
- Failure to Interrogate4
- High Capture Threshold2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Unspecified Infection27
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient6
- Pocket Erosion3
- Bacterial Infection1
- Endocarditis1
- Pain1
- Syncope/Fainting1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Premature Elective Replacement Indicator; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778910 ↗InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS AND TRICUSPID VALVE REPLACEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 25415367 ↗InjuryJul 24, 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 22593425 ↗MalfunctionFeb 25, 2025Failure to Interrogate; Failure to Interrogate
DEVICE COULD NOT BE INTERROGATED. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21464795 ↗InjuryJan 6, 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 21080150 ↗MalfunctionJan 26, 2024Failure to Interrogate; Failure to Interrogate
DEVICE COULD NOT BE INTERROGATED. NO ADVERSE PATIENT EVENTS WERE REPORTED. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18589003 ↗InjuryJan 11, 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 18495326 ↗MalfunctionJul 12, 2023Battery Problem; Battery Problem
PATIENT HAD A SYNCOPAL EPISODE. A BATTERY ERROR WAS RECEIVED UPON INTERROGATION. PATIENT WAS ADVISED TO FOLLOW UP WITH THE DEVICE CLINIC ASAP. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Syncope/Fainting
MAUDE report 17312922 ↗InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO EROSION/INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 17163786 ↗MalfunctionMay 18, 2023Failure to Interrogate; Failure to Interrogate
DEVICE COULD NOT BE INTERROGATED. NO ADVERSE PATIENT EVENTS REPORTED. DEVICE REMAINS IMPLANTED AND WILL BE EVALUATED FURTHER. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16953247 ↗MalfunctionMar 14, 2023Failure to Interrogate; Failure to Interrogate
DEVICE IS UNABLE TO BE INTERROGATED. 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 16536938 ↗InjuryNov 2, 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 15715185 ↗MalfunctionSep 1, 2022Battery Problem; Battery Problem
THIS DEVICE WAS EXPLANTED DUE TO 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 15335039 ↗MalfunctionAug 23, 2022Premature 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 15280224 ↗MalfunctionJul 19, 2022Premature Elective Replacement Indicator; Battery Problem; Premature Elective Replacement Indicator; Battery Problem
ERROR MESSAGE UPON INTERROGATION, BATTERY ERROR. DEVICE WAS FOUND TO BE ERI. 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 15056722 ↗MalfunctionMar 24, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE SHOWED UNEXPECTED BATTERY BEHAVIOR AND EXPLANT IS PLANNED. DEVICE CURRENTLY 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 13872269 ↗InjuryJan 27, 2022Adverse 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 13368491 ↗MalfunctionDec 23, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
DEVICE EXPLANTED DUE TO DEVICE MALFUNCTION INVOLVING AN INABILITY TO SENSE PATIENT MOTION PROPERLY. 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 13078992 ↗InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXTRACTION DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 13027948 ↗InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 12721053 ↗InjuryOct 8, 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 12600539 ↗InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 12454526 ↗MalfunctionAug 24, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
IT WAS REPORTED THAT THIS DEVICE SHOWED AN ERROR MESSAGE - BATTERY ERROR DETECTED - BEFORE EXPLANT. DEVICE WAS EXPLANTED AT ERI AND RETURNED FOR ANALYSIS. THE DESTRUCTIVE ANALYSIS REVEALED A BATTERY ISSUE. 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 12358944 ↗InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS NOT IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 12087237 ↗InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIS SYSTEM WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11920768 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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