Evera S DRRecalls & reported problems across all models

We found 8 models of Evera S DR by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 384 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 25, 2026 — classified as 16 deaths, 261 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (98 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Evera S DR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 10, 2023Open, 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-1710-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 10, 2023Open, 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-1709-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Feb 3, 2021Open, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1305-2021 · Root cause: Device Design · names 4 of these models · Recall details · FDA record ↗

4. Dec 19, 2017Terminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0587-2018 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

Most reported Evera S DR problems

Evera S DR models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Evera™ S DR DDBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths143 reports
• Evera™ S DR DDBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls7 deaths123 reports
• Evera™ S DR DDBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death53 reports
• Evera™ S DR DDBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall1 death25 reports
• Evera™ S DR DDBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall13 reports
• Evera™ S DR DDBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall7 reports
• Evera™ S DR DDBC3D1

  Implantable cardioverter defibrillator (non-CRT)
  16 reports
• Evera™ S DR DDBC3D4

  Implantable cardioverter defibrillator (non-CRT)
  4 reports

Recent Evera S DR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Sepsis

  MAUDE report 50903231 ↗
• InjurySep 14, 2026Device Sensing Problem

  It was reported by the patient that their Implantable Cardioverter Defibrillator (ICD) "went off during the night" and they "felt funny" and was "coming in and out of it". The patient also stated that they "fainted and fell" and remembered  "coming back" and "gasping for air". The ICD remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Dyspnea; Fall; Shock from Patient Lead(s); Syncope/Fainting

  MAUDE report 50757021 ↗
• InjuryJun 29, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO SYNCOPE. A DEVICE INTERROGATION INDICATED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TREATED AN EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF) THAT MAY HAVE BEEN VENTRICULAR TACHYCARDIA (VT). THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING DURING THE EPISODE THOUGH THERE APPEARED TO BE NO IMPACT TO DEVICE FUNCTION. THE ICD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 25649637 ↗
• MalfunctionMay 20, 2026Electromagnetic Interference; Device Sensing Problem

  IT WAS REPORTED THAT ELECTROMAGNETIC INTERFERENCE RESULTED IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MISCLASSIFYING AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE. 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 25228120 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE INFECTION WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS AND SEPSIS WAS NOTED.

  Patient problems: Drug Resistant Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 24401279 ↗
• InjuryFeb 3, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ELECTROMAGNETIC INTERFERENCE FROM AN ITEM PURCHASED BY THE PATIENT AND THE PATIENT WAS SHOCKED SEVERAL TIMES. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24251156 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23908361 ↗
• InjuryDec 16, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT TWO DAYS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) A SET SCREW REPOSITIONING PROCEDURE WAS PERFORMED. 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 23821169 ↗
• MalfunctionDec 16, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED ELECTROMAGNETIC INTERFERENCE THAT RESULTED IN OVERSENSING ON THE RIGHT ATRIAL (RA) CHANNEL AND MISCLASSIFICATION OF EPISODES. THE ICD WAS EXPLANTED APPROXIMATELY A WEEK LATER DUE TO NORMAL BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821077 ↗
• MalfunctionDec 11, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  Approximately nine months later, EMI/noise was noted on stored episodes triggering episode misclassification.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780021 ↗
• MalfunctionDec 10, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED STEADILY INCREASING PACING IMPEDANCE, AND TRENDS SHOWED A SIGNIFICANT JUMP IN IMPEDANCE VALUE FOLLOWED BY A NEW HIGH BASE LINE. IN ADDITION, THERE WERE HIGH RV CAPTURE THRESHOLDS. IT WAS FURTHER REPORTED THAT THE GRADUAL RISE IN IMPEDANCE AND THRESHOLDS WERE SUSPECTED TO BE RELATED TO POSSIBLE MINERALIZATION OF THE TIP ELECTRODE. IN ADDITION, ON THE DAY THAT THE PHYSICIAN WAS PLACING AN ATRIOVENTRICULAR FISTULA, THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND AN ELEVATED SENSING INTEGRITY COUNTER (SIC). OVERSENSING AND NOISE/ ELECTROMAGNETIC INTERFERENCE (EMI) WERE ALSO OBSERVED DURING THE PROCEDURE. THE LIA, OVERSENSING, AND NOISE/EMI WERE ALL ATTRIBUTED TO THE CAUTERY USED AT THE TIME. THE LEAD AND DEVICE 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 23769748 ↗
• MalfunctionNov 10, 2025Premature Discharge of Battery; Premature Discharge of Battery

  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23514613 ↗
• InjuryOct 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23290039 ↗
• InjuryOct 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPIES WERE DELIVERED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE DATA ALSO SHOWED FOLLOWING THE SECOND INAPPROPRIATE SHOCK, A TRUE VF ARRHYTHMIA WAS INDUCED AND WAS SUBSEQUENTLY TREATED WITH AN ADDITIONAL HIGH-VOLTAGE DEFIBRILLATION SHOCK. 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); Ventricular Fibrillation

  MAUDE report 23289447 ↗
• InjuryOct 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DATA TRANSMITTED FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23289442 ↗

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