Evera MRI™ XT DR SureScan® DDMB1D4 (UDI 00763000059491)Recalls & reported problems
Medtronic, Inc. · ICD-DR DDMB1D4 EVERA MRI XT US IS1/DF4 · Class 3 · Implant
All models of Evera MRI XT DR SureScan (8)
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 Evera MRI XT implantable defibrillator has 1,238 adverse event reports, including 25 deaths and 914 injuries. Many reports describe the device misreading heart signals, which led to inappropriate shocks or pacing, and some describe shocks felt from the wires. There is 1 open recall, started in May 2023, about a rare chance of reduced or no energy during high-voltage shock therapy in devices with a specific component. Reports in the last 12 months (106) are fewer than in the 12 months before (178).
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
- 1,241
- Deaths reported
- 24
- Injuries reported
- 917
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,241 adverse event reports that list this exact device (DI 00763000059491), received between Feb 8, 2018 and Sep 30, 2026 — classified as 24 deaths, 917 injuries, 300 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (476 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
- May 10, 2023Class IOpen, Classified
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Z-1712-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Sensing Problem476
- Inappropriate/Inadequate Shock/Stimulation395
- Adverse Event Without Identified Device or Use Problem381
- Pacing Problem246
- Electrical /Electronic Property Problem82
- Electromagnetic Interference59
- Failure to Deliver Shock/Stimulation55
- Over-Sensing53
Patient problems
- Shock from Patient Lead(s)389
- Unspecified Infection289
- No Clinical Signs, Symptoms or Conditions278
- Tachycardia55
- Bradycardia38
- Pain27
- Syncope/Fainting27
- Bacterial Infection23
Recent adverse event reports
The 25 most recent of 1,241 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Unable to Obtain Readings; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that electrograms (EGM) data associated with the Anti-Tachycardia Pacing (ATP) was recorded for review, but there was no EGM data associated with the shock therapy. The shock treatments fell into suspended EGM. Information received on the remote transmission was reviewed by qualified personnel. It was determined that the device was functioning within normal parameters as it had reached a set of predetermined conditions that stops collecting this data. However, the patient did received an inappropriate shock for Supra Ventricular Tachycardia (SVT) misdetected as Ventricular Tachycardia (VT). The 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 50946804 ↗InjurySep 29, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) delivered inappropriate Anti-Tachycardia Pacing (ATP) and shocked for Atrial Fibrillation (AF) with Rapid Ventricular Response (RVR) which the device detected and treated as Ventricular Fibrillation (VF). The device 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 50934262 ↗InjurySep 28, 2026Pacing Problem
It was reported that the patient indicated that today several blood pressure reading were performed that showed heart rate was "45 or 46" and indicated that the device is set to 60. The patient was referred to the physician. The Implantable Cardioverter Defibrillator (ICD) remains in use.
Patient problems: Bradycardia
MAUDE report 50916593 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Wound Dehiscence
MAUDE report 50829272 ↗InjurySep 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) device may have provided inappropriate therapy for detected Ventricular Fibrillation (VF) that was suspected Atrial Tachycardia/Atrial Fibrillation (AT/AF) with Fast Ventricular Response. The device 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 50820082 ↗MalfunctionSep 15, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778313 ↗InjurySep 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
Patient problems: Shock from Patient Lead(s)
MAUDE report 50720079 ↗MalfunctionSep 9, 2026Pacing Problem; Device Sensing Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) device may have provided inappropriate Anti-Tachycardia Pacing (ATP) for detected Fast Ventricular Tachycardia (FVT) and Ventricular Tachycardia (VT) events that were suspected Supra Ventricular Tachycardia (SVT). The device 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 50691580 ↗InjurySep 8, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) device may have provided inappropriate therapy for a detected Ventricular Tachycardia (VT) episode that was suspected Atrial Tachycardia/Atrial Fibrillation (AT/AF) with fast ventricular response. The device 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 50671592 ↗InjurySep 3, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50598476 ↗MalfunctionAug 31, 2026Device Sensing Problem
It was reported that the patient presented with palpitations, upon review Right Atrial (RA) lead undersensing was observed resulting in termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes still in progress. It was also reported that the Implantable Cardioverter Defibrillator (ICD) may have inappropriately detected an Supra Ventricular Tachycardia (SVT) episode as Non-Sustained Ventricular Tachycardia. The RA lead and ICD remain in use. No further patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533170 ↗InjuryAug 28, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the patient received possible inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy from the Imp lantable Cardioverter Defibrillator (ICD) for Supra Ventricular Tachycardia (SVT) that was detected as Ventricular Tachycardia (VT). The 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 50500683 ↗MalfunctionAug 27, 2026Electromagnetic Interference; Pacing Problem; High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected events in progress. The Right Ventricular (RV) lead exhibited increasing trend of pacing impedance, high RV threshold, noise on two vectors on current electrograms (EGM). The Implantable Cardioverter Defibrillator (ICD) was stated to not be pacing as it should and the device experienced Electromagnetic Interference (EMI). The leads and device 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 50487910 ↗MalfunctionAug 25, 2026Pacing Problem; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50429358 ↗MalfunctionAug 21, 2026Electromagnetic Interference; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50380549 ↗MalfunctionAug 18, 2026Pacing Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experience bradycardia as the device paced below normal lower limits. The device remains in use. No patient complications have been reported as a result of this event.
Patient problems: Bradycardia
MAUDE report 50306976 ↗InjuryAug 14, 2026Signal Artifact/Noise; Electromagnetic Interference; High impedance; Over-Sensing; Low impedance; Unstable Impedance
It was reported that the patient was undergoing neurological electrical stimulation therapy for cancer tumors in the lungs via a vest-like system delivering electrical stimulation over a twelve hour period. This system was interfering with the implanted implantable cardioverter defibrillator (ICD), resulting in a spike and out-of-range low right atrial (RA) lead impedance with noise and oversensing observed. The right ventricular (RV) lead exhibited high, varying, and low out-of-range defibrillation impedance, as well a spike, out-of-range high, and out-of-range low RV pacing impedance values. It was reported that all lead alerts and trends were directly associated with the patient¿s use of the neurological stimulation system, and electromagnetic interference (EMI) was identified as the cause of the out-of-range measurements and oversensing. Once the patient¿s physician elected to suspend the cancer treatment, impedance measurements appeared to remain stable with no additional oversensing observed. The device currently appears to be functioning as programmed. The 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 50261982 ↗MalfunctionAug 13, 2026Pacing Problem; Device Sensing Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) delivered inappropriate Anti-Tachycardia Pacing (ATP) for a Ventricular Tachycardia (VT) that was suspected to be a Supra Ventricular Tachycardia (SVT). The ICD remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50237065 ↗InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to an infection and vegetation of the tricuspid valve. It was noted that the patient has chronic Streptococcus and the patient experienced shortness of breath and fever ten days prior to the system removal. The organism was identified as Streptococcus and the patient was treated with intravenous antibiotics and AngioVac for vegetation removal. No further patient complications have been reported as a result of this event.
Patient problems: Dyspnea; Fever; Unspecified Infection
MAUDE report 50071425 ↗MalfunctionJul 27, 2026Pacing Problem; Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037437 ↗MalfunctionJul 27, 2026Device Sensing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50037288 ↗InjuryJul 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR AN EPISODE OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR TACHYCARDIA (VT). ADDITIONALLY, THERIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN DEFIBRILLATION IMPEDANCE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25725835 ↗InjuryJul 6, 2026Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT A MAGNET WAS PLACED OVER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHILE THE PATIENT WAS IN HOSPICE. THE DEVICE STILL LOOKED LIKE IT WAS DEFIBRILLATING AS THE PATIENT'S CHEST WAS PULSATING WITH THEIR SHOULDERS POSTURING INWARD. THE ICD REMAINS IS USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 25714717 ↗MalfunctionJun 25, 2026Device Sensing Problem
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT) AND VT AS SVT. THE RA LEAD AND ICD 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 25627200 ↗InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25599038 ↗
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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