Entrant™ CDDRA300TRecalls & reported problems
St. Jude Medical, Inc. · DR Implantable Cardioverter Defibrillator · Class 3 · Implant
All models of Entrant (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067049469), received between Aug 5, 2025 and Aug 8, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Compatibility Problem” (1 report).
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
- Compatibility Problem1
- Inappropriate or Unexpected Reset1
- Inappropriate/Inadequate Shock/Stimulation1
- Over-Sensing1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 8, 2025Inappropriate or Unexpected Reset; Compatibility Problem; Inappropriate or Unexpected Reset; Compatibility Problem
DURING A CLINIC FOLLOW-UP, THE DEVICE WAS FOUND TO BE IN BACKUP VVI (BVVI) MODE. THE CAUSE OF THE BVVI WAS FOUND TO BE MRI EXPOSURE. TECHNICAL SUPPORT WAS CONTACTED AND THE DEVICE WAS REPROGRAMMED TO RESOLVE THE EVENT. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22753681 ↗InjuryAug 5, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC AS THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT-VENTRICULAR (RV) LEAD EXHIBITED INAPPROPRIATE SHOCK AS A RESULT OF OVERSENSING ELECTROMAGNETIC INTERFERENCE OF ANOTHER IMPLANTED DEVICE. THE RV LEAD EXHIBITED LOW PACING IMPEDANCE AS WELL. PROGRAMMING CHANGES WERE MADE INITIALLY TO DEACTIVATE THE ICD. ADDITIONALLY, UPON FLUOROSCOPY IMAGING IT WAS NOTED THAT THE RV LEAD EXHIBITED EXTERNALIZED CONDUCTORS, AND NOISE WAS REPRODUCIBLE BY MANIPULATING OUTPUT FREQUENCIES OF THE OTHER DEVICE. AS A RESOLUTION THE RV LEAD AND THE ICD WERE EXPLANTED AND REPLACED. THE PATIENT WAS RECOVERING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22719156 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 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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