Neutrino™ CDHFA600BRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05415067050076), received between Mar 23, 2026 and Sep 16, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (2 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-Sensing2
- Pacing Intermittently1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796782 ↗MalfunctionAug 31, 2026Over-Sensing
It was reported that during a routine generator change, upon connecting a right atrial (RA) lead, far field R-wave oversensing was observed on the newly implanted Implantable Cardioverter Defibrillator (ICD). This had not been observed on the older generator though all settings mirrored the original generator. Programming changes were made. There were no complaints on the RA lead. The new ICD remained implanted and was being monitored. The procedure was not prolonged and there were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533853 ↗MalfunctionMar 23, 2026Pacing Intermittently
IT WAS REPORTED THAT DURING A FOLLOW UP IN CLINIC, INTERMITTENT LOSS OF PACING WAS NOTED ON THE DEVICE. ABBOTT TECHNICAL SUPPORT WAS CONTACTED, HOWEVER, NO INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE PATIENT WAS IN STABLE CONDITION AND WILL CONTINUE TO BE MONITORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663211 ↗
Other Implantable pulse generator, pacemaker (non-CRT) devices
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- ACCOLADE™ MRI EL DR L331Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls22 deaths7,984 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)187 deaths7,655 reports
- ACCOLADE™ MRI DR L311Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls59 deaths7,283 reports
- Azure™ XT DR MRI SureScan™ W1DR01Medtronic, Inc. · Implantable pulse generator, pacemaker (non-CRT)107 deaths5,971 reports
- ACCOLADE™ DR L301Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls6 deaths2,513 reports
- ACCOLADE™ EL DR L321Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)2 recalls2 deaths1,906 reports
- ACUITY™ X4 Spiral S 4674Boston Scientific Corporation · Implantable pulse generator, pacemaker (non-CRT)16 deaths1,975 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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