Itrevia 7 HF-T QP DF4 IS4 401662Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Biotronik Itrevia 7 heart defibrillator with resynchronization, implanted under the skin to keep the heart rhythm steady. The 34 reports mostly describe the device or one of its leads reaching end of service much earlier than expected, so it stops delivering shocks or shocks without a real heart rhythm, and it can no longer be read by the clinic; some reports mention infection at the implant site and one describes a tear during removal. Reports include 2 deaths and 15 injuries. 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
- 34
- Deaths reported
- 2
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 04035479138769), received between Mar 21, 2017 and Jul 1, 2025 — classified as 2 deaths, 15 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Premature End-of-Life Indicator” (7 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 Problem12
- Premature End-of-Life Indicator7
- Premature Elective Replacement Indicator6
- Failure to Interrogate3
- Inappropriate/Inadequate Shock/Stimulation2
- Migration or Expulsion of Device2
- Pacemaker Found in Back-Up Mode2
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Known Impact Or Consequence To Patient10
- Unspecified Infection10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Death1
- Hematoma1
- Implant Pain1
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
PATIENT WAS LOST TO FOLLOW UP. DEVICE EXPLANTED DUE TO EOS AND UNABLE TO INTERROGATE. 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 22378555 ↗MalfunctionJul 12, 2023Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation; Premature End-of-Life Indicator; Inappropriate/Inadequate Shock/Stimulation
ERI WAS TRIGGERED ON (B)(6) 2023. THIS DEVICE THEN REACHED EOS ON (B)(6) 2023 AFTER 27 INAPPROPRIATE MAX ENERGY SHOCKS WERE DELIVERED (B)(6) 2023 DUE TO NOISE ON THE IMPLANTED RV LEAD. THE PATIENT WILL BE BROUGHT IN FOR IMMEDIATE EVALUATION. DEVICE CURRENTLY REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17305365 ↗MalfunctionMay 19, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WAS EXPLANTED AND REPLACED DUE TO END OF LIFE (EOL). 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 16969868 ↗InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
WHILE EXPLANTING LEAD AND DEVICE TO DOWNGRADE PATIENT TO A PACEMAKER SYSTEM, AN SVC TEAR OCCURRED. THE PHYSICIAN EXPLANTED THE WHOLE SYSTEM AND DID NOT IMPLANT THE NEW SYSTEM. THE PATIENT RECOVERED AND A NEW PACEMAKER SYSTEM WAS IMPLANTED 3 DAYS LATER. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 16906637 ↗MalfunctionApr 20, 2023Failure to Interrogate; Failure to Interrogate
DEVICE WAS EXPLANTED DUE TO IT WOULD NOT INTERROGATE WHEN PT ARRIVED AT ER AFTER BEING LOST TO FOLLOW-UP. 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 16780095 ↗MalfunctionMar 17, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WENT FROM 35 PERCENT TO EOS ON (B)(6) 2022. THE DEVICE POTENTIALLY DELIVERED AS MANY AS 80 SHOCKS BETWEEN (B)(6) 2022 AND (B)(6) 2022. 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 13792808 ↗MalfunctionJan 14, 2022Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE IS 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 13258451 ↗InjuryNov 16, 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 12824701 ↗InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXTRACTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 12780078 ↗InjuryOct 7, 2021Migration or Expulsion of Device; Migration or Expulsion of Device
DEVICE EXPLANTED DUE TO MIGRATION CAUSING THE PATIENT PAIN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Implant Pain
MAUDE report 12589465 ↗InjuryAug 9, 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 12294569 ↗MalfunctionAug 3, 2021Pacemaker Found in Back-Up Mode; Premature Elective Replacement Indicator; Pacemaker Found in Back-Up Mode; Premature Elective Replacement Indicator
DEVICE WAS INTERROGATED (B)(6) 2021 AND WAS FOUND TO BE IN BACKUP MODE. DEVICE WAS RE-INITIALIZED AND ERI APPEARED TO HAVE OCCURRED. LAST KNOWN BATTERY PERCENTAGE WAS 27 PERCENT IN (B)(6) 2021. DEVICE EXPLANTED (B)(6) 2021. 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 12267641 ↗InjuryMay 14, 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 11827836 ↗MalfunctionApr 22, 2021Failure to Interrogate; Failure to Interrogate
CLINICIAN REPORTED BEING UNABLE TO INTERROGATE THE DEVICE DURING A RECENT OFFICE VISIT. DEVICE IS TRANSMITTING TO HOME MONITORING AND SHOWS GREATER THAN 30 PERCENT BATTERY REMAINING. PATIENT HAS A HIGH BMI. TROUBLESHOOTING OPTIONS WERE DISCUSSED FOR THEIR NEXT VISIT. DEVICE REMAINS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11710789 ↗MalfunctionDec 22, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
THIS ICD WAS REPLACED DURING AN RV LEAD REVISION BECAUSE THE SET SCREW WAS NOT SECURING FIRMLY. A NEW CRTD WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11060038 ↗InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM REMOVED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 10985348 ↗InjuryOct 13, 2020Adverse 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 10670686 ↗InjuryOct 8, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
PATIENT WAS UNDERGOING SURGERY. MAGNET WAS PLACED TO DISABLE TACHYCARDIA THERAPY. PATIENT RECEIVED 2 SHOCKS AND DOCTOR RECEIVED A SHOCK. AFTER SHOCKS, SURGEON SWITCHED TO BIPOLAR CAUTERY. DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Shock from Patient Lead(s)
MAUDE report 10652627 ↗MalfunctionMay 15, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
ERI. LV LEAD THRESHOLDS EXTREMELY HIGH, WHICH LED TO EARLY 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 10061205 ↗MalfunctionFeb 3, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. 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 9662457 ↗MalfunctionDec 11, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. PATIENT HAD RECEIVED MORE THAN 90 APPROPRIATE SHOCKS SINCE THE DEVICE WAS IMPLANTED. THRESHOLDS ON THE RV AND LV LEAD WERE WITHIN RANGE, NO NOISE OR INAPPROPRIATE SHOCKS DETECTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9453088 ↗MalfunctionNov 20, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. THE PATIENT HAD AN LV LEAD PROGRAMMED TO MAX OUTPUT, WHICH MAY HAVE CONTRIBUTED TO THE EARLY 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 9349294 ↗MalfunctionOct 18, 2019Migration or Expulsion of Device; Migration or Expulsion of Device
PATIENT REPORTED EXPERIENCING DEVICE MIGRATION. WHEN SHE LIES ON HER RIGHT SIDE, THE DEVICE FLIPS OVER, AND WHEN SHE LIES ON HER LEFT SIDE, IT FEELS LIKE IT SLIDES INTO HER ARM. PATIENT ALSO DESCRIBED EXPERIENCING LITTLE SHOCKS, ALTHOUGH IT IS UNCLEAR WHETHER THIS IS RELATED TO THE DEVICE OR TO ANXIETY. MIGRATION IS INTERFERING WITH SLEEP, BUT NO OTHER SIDE EFFECTS WERE REPORTED. REMOTE INTERROGATION OF DEVICE DID NOT SHOW ANY ARRHYTHMIAS OR SHOCKS. DEVICE REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9209440 ↗MalfunctionSep 17, 2019Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE IS AT EOS. PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO RV LEAD NOISE, WHICH MAY HAVE CONTRIBUTED TO EARLY BATTERY DEPLETION. DEVICE AND LEAD REMAIN IMPLANTED, BUT PATIENT WILL BE SCHEDULED FOR AN EXPLANT AT TA FUTURE DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9078435 ↗InjuryAug 15, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
AFTER DELIVERING 45 SHOCKS WITHIN A FEW HOURS DUE TO LEAD NOISE, DEVICE WENT FROM 62 PERCENT BATTERY TO 32 PERCENT. ALSO, DUE TO NECESSARY HIGH LV OUTPUT, MD DECIDED TO CHANGEOUT TO A NEW CRT-D. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8897319 ↗
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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