Aurora EV-ICD™ MRI SureScan™ DVEA3E4Recalls & reported problems
Medtronic, Inc. · ICD-VR DVEA3E4 EV-ICD EV4 US RW UPDATE · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Medtronic Aurora EV-ICD defibrillator is implanted under the breastbone to treat irregular heart rhythms. Its 215 reports include 157 injuries and 9 deaths. Many reports describe trouble detecting heartbeats, inappropriate shocks, and pain or discomfort at the implant site, and some describe the device being removed and replaced. There is 1 open recall, from October 2025, over a rare sequence of events that could delay high-voltage therapy.
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
- 225
- Deaths reported
- 9
- Injuries reported
- 164
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 225 adverse event reports that list this exact device (DI 00763000368470), received between Feb 2, 2024 and Sep 30, 2026 — classified as 9 deaths, 164 injuries, 52 malfunctions.
The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (61 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Oct 29, 2025Class IIOpen, Classified
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Z-0726-2026 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Inappropriate/Inadequate Shock/Stimulation61
- Device Sensing Problem60
- Adverse Event Without Identified Device or Use Problem48
- Electromagnetic Interference41
- Signal Artifact/Noise21
- Failure to Convert Rhythm17
- Over-Sensing15
- Appropriate Device Problem Term/Code Not Available14
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- Shock from Patient Lead(s)62
- Unspecified Infection22
- Discomfort21
- Erythema16
- Pain14
- Purulent Discharge13
- Wound Dehiscence10
Recent adverse event reports
The 25 most recent of 225 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
Patient problems: Shock from Patient Lead(s)
MAUDE report 50951352 ↗InjurySep 30, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient received an inappropriate shock due to Electromagnetic Interference that was detected as Ventricular Fibrillation (VF). The Extravascular Implantable Cardioverter Defibrillator (EV-ICD) remains in use. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50947865 ↗MalfunctionSep 29, 2026Migration or Expulsion of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936297 ↗MalfunctionSep 28, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924059 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was further reported that per the physician there was no infection, but pocket erosion occurred.
Patient problems: Discomfort; Pocket Erosion; Swelling/ Edema; Unspecified Infection
MAUDE report 50876069 ↗InjurySep 23, 2026Failure to Convert Rhythm
It was reported that the day of the procedure, defibrillation threshold testing (DFT) failed at 35 joules. The next day, there was failed DFT at 35 joules and 40 joules. Two days after implant the Extravascular Implantable Cardioverter Defibrillator (EV-ICD) and the Extravascular (EV) lead were explanted and replaced two days later. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869278 ↗InjurySep 18, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Shock from Patient Lead(s)
MAUDE report 50828673 ↗MalfunctionSep 11, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739621 ↗InjurySep 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the patient received inappropriate shocks and inappropriate Anti-Tachycardia Pacing (ATP) for Supra Ventricular Tachycardia (SVT) detected as Ventricular Tachycardia (VT). In addition, the patient received manual cardioversion. The Extravascular Implantable Cardioverter Defibrillator (EV-ICD) remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50714357 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Extravascular Implantable Cardioverter Defibrillator (EV-ICD) was removed and replaced with a transvenous d efibrillator system due to discomfort and pain at the implant site making the patient unable to resume usual activities. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Pain
MAUDE report 50355547 ↗MalfunctionAug 14, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256380 ↗MalfunctionAug 14, 2026Electromagnetic Interference; Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255541 ↗InjuryAug 13, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the patient received inappropriate shocks for Supra Ventricular Tachycardia (SVT) in the Ventricular Fibrillation (VF) zone after receiving an appropriate shock for Ventricular Tachycardia (VT). The Extravascular Implantable Cardioverter Defibrillator (EV-ICD) remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50241517 ↗InjuryAug 4, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the patient received an inappropriate shock due to Supra Ventricular Tachycardia (SVT) that was detected as Ventricular Fibrillation (VF). The patient was operating a chain saw at the time. VF detection was increased and the blank after sense was decreased. The Extravascular Implantable Cardioverter Defibrillator (EV-ICD) remains in use. The patient is a participant in a clinical study. No patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50133794 ↗InjuryAug 4, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the patient received an inappropriate shock for atrial fibrillation/atrial flutter that was detected as Ventricular Fibrillation (VF). The Extravascular Implantable Cardioverter Defibrillator (EV-ICD) remains in use. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50132847 ↗InjuryJul 30, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the Extravascular Implantable Cardioverter Defibrillator (EV-ICD) patient was inappropriately shocked due to Atrial Fibrillation (AF) with Rapid Ventricular Response (RVR) detected in the Ventricular Fibrillation (VF) zone. The EV-ICD remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50086404 ↗InjuryJul 29, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation
It was reported that an Extravascular Implantable Cardioverter Defibrillator (EV-ICD) patient received an inappropriate shock while swimming by a dock, with electromagnetic interference alleged as the source. The patient was brought into a cardiology office and no reprogramming was performed. The EV-ICD remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Shock from Patient Lead(s)
MAUDE report 50077374 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced discomfort, pain, purulent discharge/pus and redness due to a staphylococcus aureus infection from the sternal incision. The Extravascular Implantable Cardioverter Defibrillator (EV-ICD) and the Extravascular (EV) lead were explanted and not replaced. No further patient complications have been reported as a result of this event.
Patient problems: Bacterial Infection; Discomfort; Erythema; Pain; Purulent Discharge
MAUDE report 50008069 ↗InjuryJun 26, 2026Failure to Convert Rhythm
IT WAS REPORTED THAT DEFIBRILLATION THRESHOLD TESTING FAILED TO RESCUE ALONG WITH EXTERNAL SHOCKS. THE VECTOR WAS REPROGRAMMED AND THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) WAS REPOSITIONED MORE ANTERIOR. THE EV-ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25638834 ↗InjuryJun 23, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing
IT WAS REPORTED THAT THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) CLASSIFIED AN EPISODE AS OVERSENSING NOISE. IT WAS DETERMINED THAT THE PATIENT WORKS IN A COAL MINE AND WAS NEAR A HIGH-FREQUENCY MACHINE AT THE TIME OF THE EPISODE, AND EXTRAVASCULAR (EV) LEAD NOISE WAS RECREATED WITH ISOMETRIC MOVEMENTS OF THE PATIENTS LEFT ARM. SINCE THE MACHINE AND POSITIONAL CHANGES MAY HAVE BOTH CONTRIBUTED TO THE EPISODE, OVERSENSING PROTECTION WAS INCREASED TO 6 WHERE ONLY A MINIMAL AMOUNT OF NOISE WAS STILL VISIBLE ON ELECTROGRAMS (EGM) BUT WAS NOT MARKED AS SENSED WITH ADDITIONAL ISOMETRIC MANEUVERS. THE EV-ICD AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25596457 ↗DeathJun 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THIRTEEN DAYS POST-IMPLANT OF AN EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) SYSTEM, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS PROVIDED BY THE PHYSICIAN AS PULSELESS ELECTRICAL ACTIVITY (PEA ARREST). THE DISPOSITION OF THE EV-ICD SYSTEM IS CURRENTLY UNKNOWN.
Patient problems: Cardiac Arrest
MAUDE report 25523243 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT THEY ARE ALMOST A YEAR OUT FROM SURGERY AND THEY STILL "GET A HOLE; THE SCAR TISSUE WILL TUNNEL A HOLE OVER THE IMPLANT SITE" AND THE SITE "KEEPS REOPENING". THE PATIENT HAS BEEN GIVEN A "THICK SILICONE PADDING; LIKE A BANDAGE"TO WEAR OVER THE SITE. THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Wound Dehiscence
MAUDE report 25448023 ↗InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) SYSTEM WAS REMOVED DUE TO DISCOMFORT. A TRANS VENOUS SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Discomfort
MAUDE report 25372455 ↗MalfunctionMay 25, 2026Electromagnetic Interference
IT WAS REPORTED THAT A STORED EPISODE FOR OVERSENSING WAS OBSERVED WHICH WAS NOTED TO BE ELECTROMAGNETIC INTERFERENCE. THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273361 ↗MalfunctionMay 21, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing
IT WAS REPORTED THAT THE EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) RECORDED EPISODES OF OVERSENSING NOISE SUSPECTED TO BE RELATED TO AN EXTERNAL SOURCE OF ELECTROMAGNETIC INTERFERENCE (EMI). THE EV-ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247655 ↗
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 · each recall links to the FDA recall notice
- 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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