Intica Neo 7 HF-T QP DF-1 IS4 ProMRI 429552Recalls & reported problems
BIOTRONIK SE & Co. KG · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Intica Neo 7 HF-T is an implanted heart defibrillator with resynchronization (CRT-D), a pacemaker-like device that shocks the heart and coordinates its beating. The 28 reports mostly describe units being removed because of infection around the implant, along with one device that could no longer be read by the programmer, high impedance readings, and a battery reaching end-of-life sooner than expected. Reports mention 1 death and 21 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
- 28
- Deaths reported
- 1
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04035479156824), received between Mar 10, 2021 and Apr 16, 2026 — classified as 1 death, 21 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Interrogate” (3 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 Problem21
- Failure to Interrogate3
- Battery Problem1
- High impedance1
- Pacing Problem1
- Premature Elective Replacement Indicator1
Patient problems
- Unspecified Infection19
- No Clinical Signs, Symptoms or Conditions7
- Sepsis3
- Ischemia1
- Pocket Erosion1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Premature Elective Replacement Indicator
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 24895427 ↗InjuryJan 15, 2026Adverse 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 24087008 ↗InjuryDec 3, 2025Adverse 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 23704617 ↗MalfunctionAug 29, 2025Failure to Interrogate; Failure to Interrogate
CLINICIAN REPORTED AN INABILITY TO INTERROGATE THE DEVICE. A FORCED INTERROGATION ATTEMPT RESULTED IN THE ERROR MESSAGE: UNABLE TO IDENTIFY DEVICE TYPE. ADDITIONALLY, A FORCED RAM DUMP WAS UNSUCCESSFUL. ALL STANDARD TROUBLESHOOTING PROCEDURES TO ESTABLISH COMMUNICATION WITH THE DEVICE WERE EXHAUSTED. THE DEVICE LAST TRANSMITTED TO HMSC ON JUNE 10, 2025, SHOWING A BATTERY STATUS OF BOS / 100 PERCENT. THE 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 22921955 ↗InjuryAug 25, 2025Adverse 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 22887919 ↗InjuryAug 19, 2025Adverse 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 22843263 ↗InjuryJul 25, 2025Adverse 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 22621095 ↗InjuryJul 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 22461377 ↗InjuryMar 14, 2025Adverse 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 21607978 ↗InjuryAug 14, 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 19986683 ↗InjuryJan 24, 2024Adverse 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 18574510 ↗MalfunctionJan 5, 2024Failure to Interrogate; Failure to Interrogate
THIS DEVICE WAS EXPLANTED BECAUSE IT COULD NOT BE INTERROGATED FOLLOWING EXTERNAL SHOCK DURING AN ABLATION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18450373 ↗InjuryOct 25, 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 18003277 ↗InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION, VEGETATION AND SEPSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 17843168 ↗InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SYSTEM EXPLANTED DUE TO INFECTION/SEPSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 17814640 ↗InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT RECENTLY ADMITTED DUE TO INFECTION. DEVICE AND LEADS ARE STILL IMPLANTED. PATIENT AND HER MEDICAL TEAM ARE CURRENTLY DISCUSSING NEXT STEPS INCLUDING POSSIBLE EXPLANATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: Unspecified Infection
MAUDE report 17735792 ↗MalfunctionJan 5, 2023High impedance; High impedance
THIS DEVICE WAS EXPLANTED DUE TO HIGH LV LEAD IMPEDANCES THROUGH DEVICE, THEN NORMAL THROUGH PSA AFTER MULTIPLE ATTEMPTS. 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 16103761 ↗MalfunctionNov 17, 2022Battery Problem; Battery Problem
THIS DEVICE SHOWS UNEXPECTED BATTERY BEHAVIOR SEVERAL HOURS AFTER IMPLANT. 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 15815303 ↗InjurySep 14, 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 15417322 ↗InjurySep 1, 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 15341809 ↗MalfunctionJul 11, 2022Pacing Problem; Pacing Problem
DEVICE WAS EXPLANTED DUE TO INAPPROPRIATE RAPID ATRIAL PACING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14976737 ↗DeathJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT SUFFERED FROM RECURRENT FALL. THE PATIENT WAS HOSPITALIZED. BLOOD TEST AND BLOOD CULTURES WERE DONE. STAPHYLOCOCCUS AUREUS INFECTION WAS SEEN IN THE BLOOD CULTURES. THE DEVICE WAS REPROGRAMMED (DEACTIVATED) AND REMAINS IMPLANTED. THE PATIENT DIED IN THE HOSPITAL. MULTIORGAN FAILURE DUE TO SEPSIS HAS BEEN PROVIDED AS A CAUSE OF DEATH.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 14804382 ↗InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT SUFFERED FROM DISORDER OF CONSCIOUSNESS, MOTOR RESTLESSNESS BUT DID NOT MOVE THE LEFT LIMBS, MOMENTUM GRADUALLY APPEARED. TRANSIENT ISCHEMIC ATTACK WAS GIVEN AS THE CARDIOVASCULAR CAUSE. PATIENT WAS HOSPITALIZED AND BRAIN CT WAS DONE FOR DIAGNOSTICS. NO DEVICE INVOLVEMENT WAS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.
Patient problems: Ischemia
MAUDE report 14361790 ↗InjuryApr 15, 2022Adverse 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 14117860 ↗MalfunctionSep 28, 2021Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THIS DEVICE COULD NOT BE INTERROGATED FOLLOWING IMPLANTATION OF HEART MATE III LVAD. MULTIPLE ATTEMPTS WERE MADE WITH DIFFERENT COMBINATIONS OF PGH AND RF, BUT DEVICE WAS NOT ABLE TO BE INTERROGATED. PATIENT WILL BE TRANSFERRED TO A DIFFERENT ROOM AND THE REP WILL ATTEMPT INTERROGATION AGAIN. 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 12544479 ↗
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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