Neutrino™ CDHFA600DRecalls & reported problems
St. Jude Medical, Inc. · NxT HF Cardiac Resynchronization Therapy Defibrillator VVED DDDRV · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05415067050045), received between Nov 24, 2025 and Sep 29, 2026 — classified as 1 death, 1 injury, 12 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (9 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Over-Sensing9
- Failure to Interrogate2
- Adverse Event Without Identified Device or Use Problem1
- Incorrect Measurement1
- Under-Sensing1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Arrhythmia1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Over-Sensing
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing (PPTWOS). No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936056 ↗MalfunctionSep 18, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828515 ↗MalfunctionSep 14, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762798 ↗MalfunctionAug 27, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50480466 ↗DeathMay 21, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WITH A RECENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PASSED. THERE ARE NO ALLEGATIONS AGAINST ANY ABBOTT PRODUCTS OR PROCEDURES. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250857 ↗MalfunctionMay 5, 2026Over-Sensing
DURING REMOTE FOLLOW UP, POST PACED T WAVE OVERSENSING WAS OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING. NO INTERVENTION HAS BEEN PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25080659 ↗MalfunctionMar 26, 2026Over-Sensing
IT WAS REPORTED THAT DURING A REMOTE FOLLOW UP, POST-PACED T-WAVE OVERSENSING (PPTWOS) WAS NOTED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24706770 ↗MalfunctionMar 25, 2026Over-Sensing
DURING AN IN-CLINIC FOLLOW-UP, EPISODES OF FAR FIELD R-WAVE OVERSENSING (FFRWOS) WERE OBSERVED ON THE DEVICE. TECHNICAL SUPPORT WAS CONTACTED AND RECOMMENDED REPROGRAMMING TO RESOLVE THE EVENT. REPROGRAMMING HAS BEEN PERFORMED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24686385 ↗MalfunctionMar 17, 2026Over-Sensing
ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE WAS REPROGRAMMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619705 ↗MalfunctionMar 12, 2026Over-Sensing
DURING REMOTE FOLLOW UP, POST PACED T- WAVE OVERSENSING WAS OBSERVED ON THE DEVICE. TECHNICAL SERVICES WAS CONTACTED AND RECOMMENDED REPROGRAMMING. THE DEVICE WAS REPROGRAMMED TO RESOLVE THIS EVENT. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24584303 ↗MalfunctionMar 11, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING NOTED ON THE RIGHT VENTRICULAR LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. A MINOR ARRYTHMIA WAS NOTED. NO INTERVENTION WAS NOTED AND NO INFORMATION REGARDING ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Arrhythmia
MAUDE report 24573458 ↗MalfunctionFeb 19, 2026Failure to Interrogate
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED BLUETOOTH (BLE) TELEMETRY LOSS. THE ICD WAS INTERROGATED USING WAND ONLY TELEMETRY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24394101 ↗InjuryDec 28, 2025Under-Sensing; Under-Sensing
NEW INFORMATION RECEIVED NOTED THAT A RE-OCCURRENCE OF UNDER-SENSING WAS NOTED ON THE ICD AND RV LEAD. VENTRICULAR TACHYCARDIA (VT) ABLATION WAS PERFORMED TO ADDRESS THE ISSUE, HOWEVER, WAS UNSUCCESSFUL. PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE INSTEAD, AND THE PATIENT WILL CONTINUE TO BE MONITORED. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904047 ↗MalfunctionNov 24, 2025Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED, THE DEVICE WAS UNABLE TO BE CONNECTED VIA BLUETOOTH TELEMETRY TO THE REMOTE MONITORING APPLICATION. NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23639984 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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