BioMonitor IIIm 450218Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 2 · Implant
Quick summary
This Biotronik BioMonitor IIIm implantable heart monitor has 373 reports, with no deaths and 223 injuries. Many describe the device migrating out of place, clinicians being unable to read its data, and devices being removed, with wound problems and infections also mentioned. No recalls name this device. Recent reports fell from 92 to 45 compared with the period before.
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
- 373
- Deaths reported
- 0
- Injuries reported
- 223
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 373 adverse event reports that list this exact device (DI 04035479169862), received between Aug 25, 2020 and Sep 30, 2026 — classified as 223 injuries, 150 malfunctions.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (76 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem127
- Migration or Expulsion of Device76
- Failure to Interrogate57
- Device Sensing Problem47
- Ambient Noise Problem21
- Failure to Sense14
- Premature Elective Replacement Indicator14
- Communication or Transmission Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions179
- Wound Dehiscence60
- Unspecified Infection39
- Discomfort37
- Implant Pain34
- Pocket Erosion26
- Twiddlers Syndrome4
- Inflammation2
Recent adverse event reports
The 25 most recent of 373 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Interrogate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954565 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
This device was explanted due to patient complaint of discomfort. Should additional information be received this file will be updated.
Patient problems: Discomfort
MAUDE report 50802282 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
This device was explanted due to patient discomfort. Should additional information be received this file will be updated.
Patient problems: Discomfort
MAUDE report 50674108 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort; Implant Pain
MAUDE report 50576374 ↗InjurySep 2, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50569361 ↗InjuryAug 31, 2026Migration or Expulsion of Device
This device migrated out of the pocket and patient removed it. Should additional information become available, this file will be updated.
Patient problems: Wound Dehiscence
MAUDE report 50527635 ↗InjuryAug 26, 2026Device Sensing Problem
This device was explanted due to decrease in sensing post-cardioversion. 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 50456528 ↗InjuryAug 18, 2026Failure to Interrogate
This device was explanted due to unable to interrogate. Exact explant date is unknown. Should additional information be received this file will be updated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311089 ↗InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem
This device was explanted due to it was causing patient too much discomfort and he wanted it removed. Explant date was sometime in 2024, specific date unknown. Should additional information become available, this file will be updated.
Patient problems: Discomfort
MAUDE report 50224624 ↗InjuryAug 11, 2026Failure to Interrogate; Battery Problem
Loop recorder was explanted due to it will not interrogate. 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 50213495 ↗InjuryAug 7, 2026Premature Elective Replacement Indicator
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 50180857 ↗InjuryAug 5, 2026Interrogation Problem
This device was explanted due to it could not be interrogated. 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 50140610 ↗InjuryAug 3, 2026Device Sensing Problem
This device was explanted due to loss of signal after cardioversion/ablation. 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 50116845 ↗InjuryAug 3, 2026Device Sensing Problem
This device was explanted due to sensing issues. 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 50114873 ↗InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem
Device was explanted due to infection. Should additional information be received, this file will be updated.
Patient problems: Unspecified Infection
MAUDE report 50114515 ↗InjuryJul 28, 2026Interrogation Problem
This device was explanted due to it could not be interrogated. 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 50061652 ↗InjuryJun 3, 2026Failure to Interrogate; Failure to Transmit Record
THIS DEVICE WAS EXPLANTED DUE TO IT WAS NOT TRANSMITTING AND COULD NOT BE INTERROGATED. 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 25375231 ↗InjuryJun 2, 2026Device Sensing Problem
THIS DEVICE WAS IMPLANTED. AFTERWARDS THERE WAS NO SENSING POST-PROGRAMMING. DEVICE WAS THEN EXPLANTED. 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 25368169 ↗InjuryMay 15, 2026Failure to Interrogate; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI AND UNABLE TO INTERROGATION. 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 25187111 ↗InjuryMay 8, 2026Premature Elective Replacement Indicator
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 25127619 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED PER PATIENT REQUEST DUE TO BEING UNCOMFORTABLE DURING SLEEP. IT WAS KEEPING HIM UP AT NIGHT.
Patient problems: Discomfort
MAUDE report 25123401 ↗InjuryMay 7, 2026Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI. 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 25113075 ↗InjuryMay 7, 2026Malposition of Device; Device Sensing Problem
LOOP WAS EXPLANTED DUE TO IMPLANT POSITION TOO FAR UPPER LEFT/ PHYSICIAN WANTED TO CHANGE PLACEMENT FOR BETTER SENSING. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112929 ↗InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT REPORTED ONGOING PAIN AT THE IMPLANT SITE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 25029086 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO PATIENT COMPLAINT OF PAIN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Implant Pain
MAUDE report 25009845 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.