Evera MRI™ S DR SureScan™ DDMC3D1 (UDI 00643169929258)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169929258), received between Feb 6, 2019 and Aug 12, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Signal Artifact/Noise; Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222375 ↗
• MalfunctionAug 23, 2024Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THERE WAS POTENTIAL ELECTROMAGNETIC INTERFERENCE (EMI) AND OVERSENSING NOTED ON STORED ELECTROGRAMS. 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 20047720 ↗
• InjurySep 15, 2023Incorrect Measurement; Defibrillation/Stimulation Problem; Low impedance; Impedance Problem; Incorrect Measurement; Defibrillation/Stimulation Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. REVIEW OF THE EPISODE DATA SHOWED THAT MORE THAN THE PROGRAMMED HIGH-VOLTAGE ENERGY HAD BEEN DELIVERED. FOLLOWING THE HIGH-VOLTAGE THERAPY FOR VF, THERE WAS A SUBSEQUENT FALSE DROP IN PACING IMPEDANCE ON ALL PATHWAYS WHICH TRIGGERED ALERTS, AND A FALSE DECLINE IN BATTERY VOLTAGE. THE ICD WAS LATER EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17756677 ↗
• InjuryMay 25, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCKS FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT WAS DETECTED 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 17001406 ↗
• InjuryJun 21, 2021Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE RHYTHM WAS DETERMINED TO BE VENTRICULAR TACHYCARDIA (VT) AND THE PATIENT WAS SYNCOPAL.

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

  MAUDE report 12032890 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO SEPSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 11417612 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 10485404 ↗
• InjuryMar 28, 2020Unable to Obtain Readings; Reset Problem; Unable to Obtain Readings; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A RESET, AND DISPLAYED INVALID DATA. IT WAS DETER MINED THAT THE PATIENT HAD UNDERGONE RADIATION THERAPY. THE RESET WAS CLEARED, AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9894983 ↗
• InjurySep 6, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR VENTRICULAR FIBRILLATION (VF) THAT APPEARED TO BE AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8970285 ↗
• InjuryFeb 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A SYSTEMIC INFECTION AND ANTIBIOTIC TREATMENT WAS NECESSARY. IT WAS NOTED THAT THE SOURCE OF THE SYSTEMIC INFECTION IS UNKNOWN. THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8361790 ↗
• InjuryFeb 6, 2019Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT THEY RECEIVED SHOCKS FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FOLLOW UP WITH THE PATIENT'S PHYSICIAN NOTED THAT THE SHOCKS WERE INAPPROPRIATE BUT NO MALFUNCTION WAS NOTED. THE DEVICE WAS REPROGRAMMED AND THE PATIENT'S MEDICATIONS WERE ADJUSTED. 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 8309883 ↗