Itrevia 7 HF-T DF-1 393014Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Itrevia 7 HF-T is an implanted heart defibrillator with resynchronization pacing (CRT-D). Most of the 60 reports describe the device reaching end of service earlier than expected, being taken out because of infection or movement in the surgical pocket, or not reading out when a doctor tried to check it; a few mention shocks delivered without cause. Two deaths and 32 injuries were reported. 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
- 60
- Deaths reported
- 2
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 04035479129309), received between Jun 18, 2018 and Feb 9, 2026 — classified as 2 deaths, 32 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem29
- Premature Elective Replacement Indicator14
- Premature End-of-Life Indicator5
- Failure to Interrogate3
- Ambient Noise Problem2
- Inappropriate/Inadequate Shock/Stimulation2
- Migration or Expulsion of Device2
- Premature Discharge of Battery2
Patient problems
- Unspecified Infection21
- No Known Impact Or Consequence To Patient15
- No Clinical Signs, Symptoms or Conditions11
- Pocket Erosion4
- Pain2
- Shock from Patient Lead(s)2
- Bradycardia1
- Cardiac Arrest1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2026Premature 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 24297248 ↗InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 19826981 ↗MalfunctionMar 13, 2024Failure to Interrogate; Failure to Interrogate
DEVICE WILL NOT INTERROGATE. 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 18895286 ↗InjurySep 15, 2023Adverse 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 17755393 ↗MalfunctionMar 31, 2023Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT DEVICE WAS UNABLE TO BE INTERROGATED. PATIENT REPORTED SHOCKS WHEN ARRIVING AT HOSPITAL BUT THIS CANNOT BE CONFIRMED DUE TO INABILITY TO INTERROGATE. DEVICE REMAINS IMPLANTED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16659924 ↗InjuryMar 28, 2023Migration or Expulsion of Device; Migration or Expulsion of Device
DEVICE WAS EXPLANTED DUE TO MIGRATION IN THE POCKET. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Wound Dehiscence
MAUDE report 16631928 ↗MalfunctionJan 25, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE EXPLANTED DUE TO EOS DISCOVERED DURING INPATIENT 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 16241731 ↗InjurySep 9, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
PATIENTS FAMILY REPORTED THAT ON (B)(6) 2021 THE PATIENT RECEIVED INAPPROPRIATE SHOCKS AND WENT TO THE ER WHERE HIS DEVICE WAS TURNED OFF. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 15390989 ↗InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD SEPSIS ALL WAS REMOVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Sepsis
MAUDE report 15142765 ↗MalfunctionJan 20, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE IS AT EOS INDICATION AND WAS EXPLANTED AND REPLACED. 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 13307441 ↗MalfunctionJan 6, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE WAS EXPLANTED DUE TO BEING AT EOS. 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 13180231 ↗MalfunctionOct 28, 2021Migration or Expulsion of Device; Premature Elective Replacement Indicator; Migration or Expulsion of Device; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO NORMAL ERI AND MIGRATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12710661 ↗InjuryOct 12, 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 12619397 ↗DeathJul 22, 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 12210331 ↗InjuryJul 13, 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 12162826 ↗InjuryApr 21, 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 11700946 ↗InjuryApr 15, 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 11675816 ↗MalfunctionApr 1, 2021Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE CLINICIAN WAS UNABLE TO INTERROGATE THE ICD SINCE INSERTION OF LVAD. HOME MONITORING INDICATES NORMAL DEVICE FUNCTION AND DAILY TRANSMISSIONS. NUMEROUS ATTEMPTS WERE MADE WITH AND WITHOUT RF TELEMETRY AND USE OF A CAST IRON PAN FOR SHIELDING AND REPOSITIONING. 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 11604146 ↗MalfunctionApr 1, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI. 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 11603178 ↗InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE REMOVED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 11340511 ↗MalfunctionJan 13, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE 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 11163229 ↗MalfunctionDec 28, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI. NO KNOWN PATIENT ADVERSE EVENTS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11077254 ↗InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE WAS EXPLANTED AND REPLACED WITH A SMALLER DEVICE BECAUSE THE PATIENT WAS CONCERNED THAT THE DEVICE WAS TOO BIG AND MIGHT COME OUT OF THE POCKET. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: Insufficient Information
MAUDE report 10748873 ↗InjurySep 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DEVICE WAS REMOVED DUE TO INFECTION ON (B)(6) 2020. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS REPORT WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 10511608 ↗MalfunctionJun 26, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE WAS EXPLANTED DUE TO ERI. IT IS BELIEVED THAT HIGH LV THRESHOLDS CONTRIBUTED TO BATTERY DEPLETION. NO ADVERSE PATIENT EVENTS WERE REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10202575 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 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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