Itrevia 7 HF-T 393016Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04035479129323), received between Sep 13, 2016 and Aug 31, 2022 — classified as 6 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (2 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem5
- Failure to Interrogate2
- Premature Elective Replacement Indicator2
- Premature End-of-Life Indicator2
- Premature Discharge of Battery1
Patient problems
- Unspecified Infection5
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient2
- Pocket Erosion2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 15326722 ↗InjuryAug 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse 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 15188601 ↗MalfunctionJan 25, 2022Failure to Interrogate; Failure to Interrogate
COMPETITOR REPRESENTATIVE REPORTED THAT THEY WERE GOING TO BE REMOVING THE SYSTEM, BUT WERE UNABLE TO INTERROGATE THIS DEVICE. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13343018 ↗InjuryJan 11, 2022Failure to Interrogate; Failure to Interrogate
DEVICE IS BEING EXPLANTED DUE TO INFECTION AND EROSION. BEFORE THE PROCEDURE IT WAS FOUND THAT THE DEVICE IS NOT ABLE TO BE INTERROGATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 13226829 ↗MalfunctionOct 26, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO EOS. 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 12697472 ↗MalfunctionJun 4, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO AN RV LEAD FRACTURE WHICH LEAD TO EOS. 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 11942613 ↗InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED WITH INFECTION. DEVICE WAS REPLACED BUT LEADS WERE LEFT ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 10159888 ↗InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION ON AN UNSPECIFIED DATE IN 2017, AROUND 6 WEEKS PRIOR TO THE IMPLANT OF THE NEW SYSTEM ON (B)(6) 2017. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE EXPLANTING PHYSICIAN, BUT THE EXPLANT DATE HAS NOT BEEN CONFIRMED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 9325048 ↗MalfunctionAug 7, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI STATUS. COMPETITORS LV LEAD HAD HIGH THRESHOLDS, WHICH REQUIRED THE DEVICE TO BE PROGRAMMED TO HIGH OUTPUT. THIS MAY HAVE CONTRIBUTED TO EARLY BATTERY DEPLETION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8870064 ↗InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXPLANTED DUE TO EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 8438481 ↗MalfunctionSep 13, 2016Premature Discharge of Battery; Premature Elective Replacement Indicator; Premature Discharge of Battery; Premature Elective Replacement Indicator
THERE IS CONCERN THIS DEVICE MAY HAVE AN EARLY BATTERY DEPLETION. PREVIOUS DATA FROM FOLLOW-UPS WAS REVIEWED AND IT WAS NOTED INITIALLY THE IMPLANT DATE WAS ENTERED CORRECTLY, BUT WHEN THE DEVICE WAS INTERROGATED, IT WAS NOTED THE IMPLANT YEAR WAS CHANGED FROM 2015 TO 2016 WHILE MAINTAINING THE CORRECT DAY AND MONTH. ALSO OF NOTE WAS FROM (B)(6) 2016: BATTERY VOLTAGE HAD DECREASED FROM 39% TO 9% @2.63 VOLTS ON (B)(6) 2016, VOLTAGE AT IMPLANT IS NOTED TO HAVE BEEN 3.1 VOLTS. DEVICE HAS BEEN PROGRAMMED WITH NORMAL VOLTAGE AND PULSE WIDTHS WITH ACC AND VCC FEATURES ACTIVATED. A RAM DUMP WAS OBTAINED AND THE DEVICE WAS RESET WITH NO CHANGE IN BATTERY VOLTAGE OR % REMAINING. DEVICE REMAINS IMPLANTED. ANALYSIS OF THE DATA FROM THE DEVICE WAS PERFORMED AND DEVICE EXPLANT WAS RECOMMENDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 5946337 ↗
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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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