Iperia 7 HF-T DF4 ProMRI 393009Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Biotronik Iperia 7 HF-T is an implanted defibrillator with heart resynchronization (CRT-D). Of the 35 adverse event reports naming it, 19 describe injuries and no deaths were reported; most describe the unit being removed because of infection in the pocket where it sits, and others describe the battery running out far earlier than expected, prompting an early replacement. There are no recalls naming 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
- 35
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04035479129255), received between Jul 18, 2018 and Dec 9, 2025 — classified as 19 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (10 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 Problem19
- Premature Elective Replacement Indicator10
- Premature End-of-Life Indicator3
- Premature Discharge of Battery2
- High impedance1
Patient problems
- Unspecified Infection17
- No Known Impact Or Consequence To Patient10
- No Clinical Signs, Symptoms or Conditions6
- Pocket Erosion2
- Cardiopulmonary Arrest1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryDec 9, 2025Adverse 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 23760779 ↗MalfunctionJan 16, 2024Premature End-of-Life Indicator; Premature End-of-Life Indicator
DEVICE WAS EXPLANTED DUE TO EOL. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18517427 ↗InjuryOct 19, 2023Adverse 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 17966733 ↗MalfunctionFeb 1, 2023Premature End-of-Life Indicator; Premature End-of-Life Indicator
THIS DEVICE REACHED ERI IN OCTOBER 2022. ON (B)(6) 2023, DEVICE SHOWS 0 DAYS TO EOS. THE DEVICE WILL BE CHANGED OUT AS SOON AS POSSIBLE. 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 16281393 ↗InjuryJun 15, 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 14703699 ↗MalfunctionMay 23, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI. RA LEAD WAS EXHIBITING HIGH THRESHOLDS, WHICH MAY HAVE LED TO EARLY BATTERY DEPLETION. 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 14476722 ↗InjuryNov 15, 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 12815281 ↗MalfunctionJul 23, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO PREMATURE DEPLETION CAUSED BY HIGH OUTPUT ON LV LEAD. 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 12217114 ↗MalfunctionJan 11, 2021Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED AFTER APPROX. 54 MONTHS IMPLANTATION TIME, THAT EOS (END OF SERVICE) WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11152403 ↗InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXTRACTION DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11148145 ↗InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS REMOVED DUE TO AN INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 10962557 ↗MalfunctionOct 13, 2020High impedance; High impedance
DEVICE WAS EXPLANTED AND REPLACED DUE TO HIGH IMPEDANCE THAT WAS SEEN ON LEAD THAT MAY BE RESULT OF AN ISSUE WITH THE DF4 PORT AND SET SCREW AREA WITH THIS DEVICE. SHOULD ADDITIONAL INFORMATION BE OBTAINED, THIS REPORT WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10670544 ↗InjurySep 16, 2020Adverse 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 10542273 ↗InjurySep 14, 2020Adverse 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 10531041 ↗InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE THIS WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 10479939 ↗InjuryMay 14, 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 10059274 ↗MalfunctionMay 14, 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 10057975 ↗InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO EROSION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Pocket Erosion
MAUDE report 10055948 ↗InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM WAS EXPLANTED DUE TO INFECTION. THERE IS CURRENTLY NO INDICATION THAT A NEW SYSTEM HAS BEEN IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 9949252 ↗MalfunctionFeb 3, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. PATIENT HAD COMPETITOR LEADS, UNKNOWN IF LEAD ISSUES 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 9662878 ↗MalfunctionFeb 3, 2020Premature Elective Replacement Indicator; Premature 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 Known Impact Or Consequence To Patient
MAUDE report 9662552 ↗MalfunctionJan 6, 2020Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI. HIGH LV LEAD THRESHOLDS ARE BELIEVED TO BE THE CAUSE OF 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 9553041 ↗MalfunctionDec 30, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. THE DEVICE WAS PROGRAMMED AT MAX OUTPUT FOR OVER A YEAR DUE TO A MYOPORE LV LEAD WITH HIGH THRESHOLDS - 7.5V AT 1.5MS AT THE TIME OF EXPLANT. LEAD HAD STEADILY INCREASING THRESHOLDS OVER THE LAST YEAR. LV LEAD WAS EXPLANTED AND REPLACED AS WELL. 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 9531415 ↗InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS SYSTEM WAS EXTRACTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 9211375 ↗MalfunctionOct 15, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI, PATIENT HAS HIGH LV PACING THRESHOLD, WHICH 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 9194887 ↗
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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