Intica 7 HF-T QP DF-1 IS4 ProMRI 404629Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BIOTRONIK Intica HF-T QP is an implanted heart defibrillator with resynchronization (CRT-D). The 72 reports mostly describe units removed from patients because of infection, and devices that could no longer be read or that lost battery life sooner than expected; 4 deaths and 50 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
- 72
- Deaths reported
- 4
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 04035479142162), received between Jun 18, 2018 and Aug 12, 2026 — classified as 4 deaths, 50 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (8 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 Problem49
- Premature Elective Replacement Indicator8
- Device Dislodged or Dislocated2
- Failure to Interrogate2
- Premature Discharge of Battery2
- Battery Problem1
- Communication or Transmission Problem1
- Device Sensing Problem1
Patient problems
- Unspecified Infection39
- No Clinical Signs, Symptoms or Conditions14
- No Known Impact Or Consequence To Patient4
- Death3
- Hematoma3
- Discomfort2
- Cardiac Arrest1
- Chest Pain1
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
InjuryAug 12, 2026Premature Elective Replacement Indicator; Battery Problem
This device was explanted due to ERI with unexpected battery behavior. 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 50224749 ↗InjurySep 11, 2024Migration; Migration
THIS DEVICE WAS EXPLANTED DUE TO WAS ERI AND EXTREMELY DISPLACED INTO THE INFRA PECTORAL/LEFT AXILLARY AREA REQUIRING POCKET REVISION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20190051 ↗InjuryApr 25, 2024Adverse 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 19188122 ↗MalfunctionJan 23, 2023Failure to Interrogate; Failure to Interrogate
UNABLE TO INTERROGATE DEVICE. PATIENT HAS AN LVAD. 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 16230715 ↗InjuryDec 12, 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 15965320 ↗InjuryOct 10, 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 15572591 ↗MalfunctionOct 4, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THIS DEVICE WAS EXPLANTED DUE TO ERI, POSSIBLY DUE TO HIGH LV THRESHOLDS. 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 15538083 ↗MalfunctionAug 22, 2022Pacemaker Found in Back-Up Mode; Pacemaker Found in Back-Up Mode
THIS DEVICE TRIGGERED BACKUP MODE ON (B)(6) 2022. THE DEVICE WAS SUCCESSFULLY REINITIALIZED. THE PATIENT REPORTED STRONG PAIN AT THE IMPLANT SITE AROUND THE TIME OF BACKUP MODE BEING TRIGGERED. THE PAIN WAS STILL PRESENT WHEN THE PATIENT WAS SEEN IN THE CLINIC, BUT HAD LESSENED. THE PAIN WENT AWAY ALL TOGETHER AFTER RE-INITIALIZATION. DEVICE REMAINS IMPLANTED.
Patient problems: Implant Pain
MAUDE report 15265885 ↗MalfunctionMay 31, 2022Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI. 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 14552088 ↗InjuryMay 5, 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 14286128 ↗MalfunctionMar 24, 2022Premature 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 Clinical Signs, Symptoms or Conditions
MAUDE report 13871721 ↗InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 13591592 ↗InjuryDec 10, 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 12979616 ↗DeathJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PHYSICIAN WAS TRYING TO EXPLANT PREVIOUSLY CAPPED RA LEAD AND REPLACE RV LEAD. PATIENT CODED DURING PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Cardiac Arrest
MAUDE report 12099818 ↗MalfunctionJun 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
ICD EXPLANTED DUE TO UNSPECIFIED MALFUNCTION. 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 12014082 ↗InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVICE EXPLANTED DUE TO INFECTION. EXPLANT DATE IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 11950074 ↗MalfunctionMay 6, 2021Difficult to Interrogate; Difficult to Interrogate
IT WAS REPORTED THAT THIS DEVICE IS DIFFICULT TO INTERROGATE. PATIENT ALSO HAS AN LVAD IMPLANTED. 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 11786483 ↗MalfunctionApr 15, 2021Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DEVICE EXPLANTED DUE TO ERI. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11675787 ↗InjuryApr 14, 2021Adverse 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, IT WILL BE ADDED TO THIS FILE.
Patient problems: Unspecified Infection
MAUDE report 11663390 ↗InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO POCKET DISCOMFORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: Discomfort
MAUDE report 11625114 ↗InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS DEVICE WAS EXPLANTED DUE TO INFECTION. NEW SYSTEM WAS NOT IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11568878 ↗MalfunctionFeb 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
LV LEAD DISLODGED AND WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11286566 ↗InjuryFeb 2, 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 ENDOCARDITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Endocarditis
MAUDE report 11267338 ↗InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11154277 ↗InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXTRACTION DUE TO INFECTION, NO POCKET INFECTION, PATIENT HAS INFECTION ELSEWHERE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 11008196 ↗
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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