Evera MRI S DR SureScanRecalls & reported problems across all models

We found 8 models of Evera MRI S DR SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 371 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2016 and Sep 10, 2026 — classified as 12 deaths, 245 injuries, 114 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (91 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 MRI S DR SureScan 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-1716-2023 · Root cause: Under Investigation by firm · names 2 of these models · 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-1715-2023 · Root cause: Under Investigation by firm · names 2 of these models · 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 2 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-0585-2018 · Root cause: Process design · names 2 of these models · Recall details · FDA record ↗

Most reported Evera MRI S DR SureScan problems

Evera MRI S DR SureScan models

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

• Evera MRI™ S DR SureScan® DDMC3D4

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls3 deaths81 reports
• Evera MRI™ S DR SureScan® DDMC3D4

  Pulse generator, permanent, implantable
  1 recall2 deaths83 reports
• Evera MRI™ S DR SureScan™ DDMC3D1

  Implantable cardioverter defibrillator (non-CRT)
  2 recalls2 deaths24 reports
• Evera MRI™ S DR SureScan™ DDMC3D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall2 deaths73 reports
• Evera MRI™ S DR SureScan® DDMC3D4

  Pulse generator, permanent, implantable
  1 recall2 deaths68 reports
• Evera MRI™ S DR SureScan™ DDMC3D1

  Pulse generator, permanent, implantable
  1 recall13 reports
• Evera MRI™ S DR SureScan® DDMC3D4

  Pulse generator, permanent, implantable
  1 death18 reports
• Evera MRI™ S DR SureScan™ DDMC3D1

  Pulse generator, permanent, implantable
  11 reports

Recent Evera MRI S DR SureScan adverse event reports

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

• MalfunctionSep 10, 2026Pacing Problem

  Patient problems: Bradycardia

  MAUDE report 50724607 ↗
• MalfunctionAug 12, 2026Signal Artifact/Noise; Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222375 ↗
• MalfunctionJun 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED ELECTROGRAMS (EGM) EPISODES RESULTING IN MISCLASSIFICATION OF EPISODES AND RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECT AND TREATED AS FAST VENTRICULAR TACHYCARDIA (FVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED MIS-DETECTION FOR SVT THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE DEVICE AN LEAD REMAINS 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 25615154 ↗
• InjuryJun 15, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODES THAT WERE SUSPECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AND SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS NOTED THAT THE DEVICE DISCRIMINATOR INITIALLY WITHHELD THERAPY BUT THE TEMPLATE WAS OLDAND THE MATCH SCORES WERE LOW. 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 25507287 ↗
• MalfunctionMay 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH THE PATIENT¿S HEART RATE (HR) DIPPING IN THE FORTIES ON TELEMETRY. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON ELECTROGRAMS DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND ALSO LEADING TO UNNECESSARY ATRIAL PACING. 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: Bradycardia

  MAUDE report 25154580 ↗
• 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 ↗
• MalfunctionApr 3, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY RECENTLY HAD THEIR DEVICE'S LOWER RATE SETTING ADJUSTED AND THEY STARTED GETTING SOME ERRATIC HEART RATE READINGS. THE PATIENT INDICATED THEY HAD HEART RATES IN THE FORTIES, AND AS LOW AS THIRTY-THREE BEATS PER MINUTE. THE PATIENT INQUIRED IF THEIR DEVICE WAS FUNCTIONING CORRECTLY. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Irregular Pulse

  MAUDE report 24779562 ↗
• 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 ↗
• DeathMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DECEASED WITH THE CAUSE OF DEATH NOTED AS COMPLICATIONS OF A CEREBRAL VASCULAR ACCIDENT AND GASTROINTESTINAL BLEEDING. THE PATIENT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 24524499 ↗
• 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 ↗
• InjuryFeb 18, 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) OTHER 1:1 DISCRIMINATOR WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). 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 24381572 ↗
• MalfunctionFeb 17, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THERE WAS ELECTROMAGNETIC INTERFERENCE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERING EPISODE M ISCLASSIFICATION. 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 24365362 ↗
• InjuryJan 7, 2026Mechanical Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK AND PRESENTED TO THE ER (EMERGENCY ROOM). THE FIELD REP ATTEMPTED WITHOUT SUCCESS TO RECREATE OVERSENSING, BUT WAS OBSERVED BOTH BIPOLAR AND RVTIP TO RVCOIL ON THE RIGHT VENTRICULAR (RV) LEAD. THE ATRIAL LEAD AND RV LEAD ALSO SHOWED LOSS OF CAPTURE AND OVERSENSING. THE RV LEAD ALSO HAD HIGH THRESHOLD. IT WAS NOTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SIC (SENSING INTEGRITY COUNTER), A HIGH RV THRESHOLD WAS TRIGGERED, AND THERE WAS HIGH AND UNDEFINED PACING IMPEDANCE FOR THE RV LEAD. CURRENTLY DETECTIONS ARE PROGRAMMED OFF UNTIL THE PATIENT CAN SEE THEIR CARDIOLOGIST. IT WAS FURTHER REPORTED BY THE PATIENT THAT TWO TO THREE DAYS AFTER THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPLACEMENT, THE DEVICE SHOCKED THEM. THE PATIENT STATED THAT THEY CALLED AND STATED THAT "IT WAS NOT RIGHT" AND THAT THE CLINICIAN TURNED OFF THE LEAD. THE PATIENT CONTINUED, "WHEN THE LEAD WAS CONNECTED, IT WAS NOT DONE CORRECTLY. THEY REDID THE SURGERY TO RECONNECT IT." ADDITIONALLY, THE PATIENT STATED THAT THEY "WOKE UP WHEN THEY WERE SEWING" THEM BACK UP AND THEY "COULD F EEL EVERYTH

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23991349 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls