Evera™ S VR DVBC3D4 (UDI 00643169017887)Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00643169017887), received between Dec 9, 2016 and May 28, 2026 — classified as 1 death, 92 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (28 reports).

2 FDA recall records 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE INCORRECT PHONE NUMBER WAS BEING CONTACTED WHEN THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS HAVING ISSUES. THE CONTACT INFORMATION WAS UPDATED. 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 25319293 ↗
• InjuryApr 10, 2026Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840996 ↗
• InjuryFeb 24, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INITIALLY INAPPROPRIATELY WITHHELD THERAPY FOR A DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DUE TO WAVELET THAT WAS SUSPECTED VENTRICULAR FIBRILLATION (VF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24431352 ↗
• InjuryFeb 17, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A POTENTIAL DETECTION ISSUE IN WHICH AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24366139 ↗
• InjuryFeb 6, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IS COMPROMISED DUE TO MULTIPLE RV ELECTRODE FRACTURES AS A RESULT OF HIGH IMPEDANCE ALERTS. ADDITIONALLY, IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED AND THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279187 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION. THE 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 24058908 ↗
• MalfunctionJan 12, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGE OUT THE DOCTOR WAS UNABLE TO LOOSEN THE SETSCREW. THE GROMMET WAS REMOVED AND THE AREA WAS FLUSHED WITH SALINE BUT THE SETSCREW WAS STILL UNABLE TO BE LOOSENED. A TORQUE WRENCH WAS ABLE TO FULLY ENGAGE TO THE SETSCREW BUT THE PHYSICIAN WAS UNABLE TO TURN COUNTERCLOCKWISE. THE PHYSICIAN STATED THEY BACKED THE SCREW ALL THE WAY OUT AT SOME POINT AND A TUG ON THE LEAD FREED FROM THE DEVICE. A CINE OF THE POCKET WAS PERFORMED TO BE SURE THE SCREW WAS NOT IN THE POCKET. NO SET SCREW WAS FOUND. THE ICD WAS SUCCESSFULLY REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049684 ↗
• InjuryJan 7, 2026Protective Measures Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT. THE ICD WAS 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 23992939 ↗
• InjuryNov 17, 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 TO AN INFECTION AND BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 23569156 ↗
• MalfunctionOct 16, 2025Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE BATTERY MEASUREMENT WENT "DOWN AND THEN BACK UP." 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 23310721 ↗
• InjuryJul 24, 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 REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22588305 ↗
• InjuryMar 7, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) FOR VENTRICULAR TACHYCARDIA (VT) AND WAS EXTERNALLY CARDIOVERTED. IT WAS NOTED THAT THERE WAS A POTENTIAL FOR INAPPROPRIATE WITHHOLDING OF THERAPY DUE TO WIDE COMPLEX QRS SEEN ON STORED SUPRA VENTRICULAR TACHYCARDIA (SVT) ELECTROGRAMS (EGM). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21554218 ↗
• InjuryJan 3, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THERE WAS A FLUCTUATION OF BATTERY LONGEVITIES. THE ICD WAS 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 21073870 ↗
• InjuryOct 16, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING A SHOCK. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT WAS TREATED WITH SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) BUT THE RHYTHM WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 20463343 ↗
• MalfunctionSep 13, 2024Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT WAS IN SURGERY WHEN A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE LIA WAS DUE TO CAUTERY FROM SURGERY. 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 20215913 ↗
• InjuryAug 14, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY LONGEVITY HAS SHOWN AN ESTIMATION OF ONE MONTH FOR THE PAST SIX MONTHS. 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 19982127 ↗
• InjuryAug 13, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BATTERY EXHIBITED PREMATURE DEPLETION. THE BATTERY HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS EXPLANT AND REPLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977755 ↗
• InjuryJul 9, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR EPISODES THAT WERE DETERMINED TO BE SINUS TACHYCARDIA. THE ICD DETECTED THE EPISODES 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 19706750 ↗
• InjuryJul 2, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 19659210 ↗
• InjuryJun 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE NOT FEELING GOOD AND STATED THEY HAD A HEART ATTACK NINE MONTHS AGO. THE PATIENT FURTHER STATED A COUPLE OF WEEKS AGO THEIR ARM HAD SWOLLEN UP AND WAS FOUND TO HAVE TWO BLOOD CLOTS IN THEIR ARM AND SHOULDER. PER THE PATIENT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT DO ANYTHING. THE PATIENT WAS HOSPITALIZED AND WAS INFORMED BY THE PHYSICIAN THAT THE BLOOD CLOTS WERE POTENTIALLY CAUSED BY THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT ALSO NOTED THAT THEY WERE IN THE HOSPITAL A MONTH AGO FOR A SEPARATE HEART EVENT AND NOW THEY ARE ON A BUNCH OF HEART MEDICATIONS. THE ICD AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Malaise; Myocardial Infarction; Swelling/ Edema

  MAUDE report 19635406 ↗
• MalfunctionJun 10, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIC HEART RATE THAT WERE IN THE 30S BEATS PER MINUTE (BPM) WHEN THEIR PROGRAMMED LOWER RATE WAS 50 BPM. THE  IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19503831 ↗
• InjuryApr 9, 2024Premature Discharge of Battery; Failure to Interrogate; Pacing Problem; Premature Discharge of Battery; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC AFTER HEARING DEVICE TONES. THE CLINICIAN WAS UNABLE TO MAKE TELEMETRY WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) VIA MULTIPLE PROGRAMMERS, AND WAS UNABLE TO HEAR ANY TONES WHEN USING A MAGNET DIRECTLY ON THE DEVICE. THE MOST RECENT INTERROGATION REPORT FROM THE END OF (B)(6) 2024 INDICATED THAT THERE WAS 2.2 YEARS OF BATTERY LIFE LEFT. THE PHYSICIAN DETERMINED THE DEVICE WAS DEAD AND THE PATIENT WAS SENT DIRECTLY TO THE EMERGENCY ROOM FOR SAME DAY CHANGEOUT IN LAB. PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PATIENT WAS ADMITTED TO HOSPITAL AND ATTEMPTS WERE MADE AGAIN TO ESTABLISH TELEMETRY WITH ICD WITHOUT SUCCESS. PATIENT WAS THEN PREPPED FOR A DEVICE CHANGE OUT. THE ICD WAS 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 19070295 ↗
• InjuryMar 28, 2024Electrical /Electronic Property Problem; Battery Problem; Reset Problem; Electrical /Electronic Property Problem; Battery Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED END OF SERVICE (EOS) AND EXHIBITED A FULL POWER ON RESET (POR). AFTER THE POR, THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH/UNDEFINED RV COIL IMPEDANCE AND THERE WAS CONCERN FOR A LEAD FRACTURE. HOWEVER, THE PACING IMPEDANCE AND SENSING WERE NORMAL, AND NO NOISE WAS REPRODUCED WITH PATIENT MANEUVERS. DEVICE DATA WAS REVIEWED BY QUALIFIED ENGINEERING PERSONNEL WHICH INDICATED THAT 3 PORS OCCURRED, AND THE HIGH RV COIL IMPEDANCE WAS LIKELY A MISS-MEASUREMENT CAUSED BY A VERY LOW BATTERY VOLTAGE. THE ICD WAS EXPLANTED AND REPLACED. THE RV LEAD TESTED NORMAL WITH NO IMPEDANCE ISSUES NOTED ON THE ANALYZER AND 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 19001014 ↗
• InjuryMar 20, 2024Adverse 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 TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18939717 ↗
• InjuryFeb 28, 2024Premature Discharge of Battery; Reset Problem; Premature Discharge of Battery; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED THE RECOMMENDED REPLACEMENT TIME (RRT) INDICATOR. THREE DAYS LATER, THE ICD TRIGGERED THE END OF SERVICE (EOS) INDICATOR AND WAS SUSPECTED TO HAVE DEPLETED PREMATURELY BETWEEN RRT AND EOS. TWO DAYS AFTER THE ICD REACHED EOS, THE ICD EXPERIENCED A FULL POWER ON RESET (POR). THE ICD WAS 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 18798997 ↗