Evera MRI™ S DR SureScan® DDMC3D4 (UDI 00763000059705)Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00763000059705), received between May 14, 2018 and Sep 10, 2026 — classified as 2 deaths, 42 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (22 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.

Recalls naming this device

1. 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-1716-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Pacing Problem

  Patient problems: Bradycardia

  MAUDE report 50724607 ↗
• InjuryMay 7, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD DISPLAYED UNDERSENSING ON STORED EPISODES OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RA 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 25119611 ↗
• InjuryMay 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK FOR AN EPISODE OF SUPRA VEN TRICULAR TACHYCARDIA (SVT) WITH SHORT RUN OF VENTRICULAR TACHYCARDIA (VT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 25095935 ↗
• InjuryApr 10, 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 SUPRA VENTRICULAR TACHYCARDIA (SVT) 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 24840874 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A SYSTEMIC INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24546101 ↗
• InjuryFeb 24, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCK THERAPY AND THE PHYSICIAN WAS UNCERTAIN WHETHER THE TREATED RHYTHM WAS SUPRAVENTRICULAR TACHYCARDIA (SVT) OR VENTRICULAR TACHYCARDIA (VT), RAISING CONCERNS REGARDING THE APPROPRIATENESS OF THE DELIVERED THERAPY. AFTER CONSULTING WITH ELECTROPHYSIOLOGY SPECIALISTS, A REQUEST WAS MADE TO REPROGRAM THE DEVICE TO PREVENT FUTURE INAPPROPRIATE SHOCKS. IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS PERFORMED AND PATIENT MEDICATIONS WERE ALSO MODIFIED. 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 24433163 ↗
• InjuryDec 17, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI -TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY. IT WAS NOTED AN EPISODE IN THE VENTRICULAR FIBRILLATION (VF) THAT WAS DETECTED AS ATRIAL FIBRILLATION (AF) WITH FAST VENTRICULAR RATES VERSUS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING RESULTING IN MISCLASSIFICATION OF VENTRICULAR TACHYCARDIA (VT) NON-SUSTAINED E PISODE. THE ICD AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Shock from Patient Lead(s)

  MAUDE report 23827943 ↗
• InjuryNov 12, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING NOTED ON A STORED EPISODE RESULTING IN THE MISCLASSIFICATION OF SVT VERSUS A VT EPISODE. THE PATIENT RECEIVED ATP THERAPY FOR THIS EPISODE. THE ICD AND 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 23529524 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE INFECTION ORGANISM WAS IDENTIFIED AS ENDOCARDITIS.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 23402828 ↗
• MalfunctionJun 26, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD SEVERAL ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES THAT SHOWED CLEAR EVIDENCE OF ELECTROMAGNETIC INTERFERENCE. 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 22342888 ↗
• InjuryJun 23, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY DELIVERED THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). 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 22310798 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE DEVICE POCKET EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 22177053 ↗
• MalfunctionMar 5, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 21526459 ↗
• MalfunctionJan 9, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT LEAD INTEGRITY ALERT WAS MISSING ON REMOTE MONITORING NETWORK QUICK LOOK REPORT. IT WAS DETERMINED THAT DURING THE PROGRAMMING SESSION LIKELY EITHER THE VENTRICULAR FIBRILLATION (VF) DETECTIONS WERE TURNED OFF, THEN ON AGAIN, OR THE THERAPY PARAMETERS WERE ADJUSTED. BOTH OF WHICH WOULD CLEAR THE LIA OBSERVATION, BUT NOT THE ALERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118450 ↗
• InjuryJan 6, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN TREATED FOR AN EPISODE VENTRICULAR FIBRILLATION (VF) BUT THE RHYTHM WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 21079219 ↗
• MalfunctionDec 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HEART RATE LOWER THAN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S (ICD) LOWER RATE SETTING. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20853043 ↗
• InjuryOct 28, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED AN UNEXPECTED CHANGE IN PROJECTED BATTERY LONGEVITY. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD DISPLAYED UNDERSENSING. THE DEVICE AND LEAD WERE REPROGRAMMED AND 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 20548163 ↗
• MalfunctionOct 18, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WHEN THEIR HEART RATE FELL BELOW THE LOWER PACING RATE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20487196 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO DEVICE POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19905902 ↗
• DeathApr 17, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE RV LEAD WAS ALSO STATED TO BE OVERSENSING. IT WAS FURTHER REPORTED THAT THE LIA WAS SUSPECTED TO BE TRIGGERED DUE TO T-WAVE OVERSENSING (TWOS), AND AN ATRIAL HIGH RATE EPISODE WAS LABELED VENTRICULAR TACHYCARDIA (VT) DUE TO OVERSENSING OF NOISE. IT WAS FURTHER REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY LABELED AN EPISODE OF SUSTAINED VT AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE PATIENT HAD REPORTED SHORTNESS OF BREATH, ABDOMINAL DISTENTION AND PERIPHERAL EDEMA. AFTER A FAMILY CONSULTATION, THE DEVICE WAS DEACTIVATED WITH USE OF A MAGNET. THE PATIENT PASSED AWAY THE NEXT DAY.

  Patient problems: Abdominal Distention; Dyspnea; Heart Failure/Congestive Heart Failure; Peripheral Edema

  MAUDE report 19124290 ↗
• InjuryMar 11, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WITHHELD THERAPIES FOR SINUS TACHYCARDIA (ST) WHEN THE EPISODE WAS SUSPECTED TO BE TRUE VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18882253 ↗
• InjuryFeb 28, 2024Failure to Deliver Shock/Stimulation; Pacing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE ATP DID NOT CONVERT THE VT, BUT INSTEAD SPED UP THE VT. THE DEVICE WAS REPROGRAMMED.

  Patient problems: Tachycardia

  MAUDE report 18797185 ↗
• InjuryFeb 20, 2024Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THEY RECEIVED SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DURING AN ABLATION ON THEIR NECK. THE PATIENT STATED THE NECK SURGEON DID NOT DO ANYTHING TO THEIR ICD BEFORE THE SURGERY. IT WAS CONFIRMED VIA FOLLOWUP WITH A DEVICE NURSE AT THE PATIENT'S FOLLOWING CLINIC THAT THE SHOCKS WERE A RESULT OF THE ABLATION PROCEDURE. 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 18737117 ↗
• MalfunctionJan 23, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT WHEN A MEDICAL EQUIPMENT COMPANY REPRESENTATIVE INTERROGATED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PRIOR TO USE, THE BATTERY STATUS INDICATOR BAR WAS GRAY. THE REPRESENTATIVE STORED THE DEVICE INDOORS FOR A WEEK AND INTERROGATED IT AGAIN, BUT THE DEVICE STILL HAD A GRAY BAR. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563672 ↗
• InjuryNov 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEPTIC AND HAD GROWTH ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS HOSPITALIZED AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 18166820 ↗