Evera™ S DR DDBC3D1 (UDI 00643169720411)Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169720411), received between Feb 25, 2019 and Dec 10, 2025 — classified as 1 death, 13 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (7 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 16, 2026.

Recalls naming this device

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-1709-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• 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 ↗
• 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 ↗
• DeathMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED ONE WEEK POST-SYSTEM REMOVAL. FOLLOW-UP WITH THE PATIENT'S CLINIC WAS UNABLE TO CONFIRM A CAUSE OF DEATH. PER AN ONLINE OBITUARY, THE PATIENT EXPIRED DUE TO HEART FAILURE.

  Patient problems: Heart Failure/Congestive Heart Failure; Unspecified Infection

  MAUDE report 22078083 ↗
• MalfunctionJun 5, 2024Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT A STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE SHOWED ATRIAL OVERSENSING CONSISTENT WITH 60 HERTZ NOISE ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 19468346 ↗
• InjuryFeb 29, 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 18810103 ↗
• InjuryAug 30, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO RECEIVING A SHOCK. A REMOTE MONITORING TRANSMISSION INDICATED THAT THE PATIENT WAS SHOCKED FOR A RHYTHM DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD OVERSENSED A BEAT AFTER A SHOCK WAS DELIVERED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 17653406 ↗
• InjuryJun 16, 2023Adverse 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 AN INFECTION. APPROXIMATELY THREE MONTHS LATER, A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17142954 ↗
• InjuryMay 23, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED, THAT THE PATIENT WAS INAPPROPRIATELY TREATED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), WITH ANTI-TACHYCARDIA PACING (ATP), AND SHOCK THERAPY. FOR DETECTING A SINUS TACHYCARDIA, AS A VENTRICULAR TACHYCARDIA (VT) EPISODE. 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 16988857 ↗
• InjuryMay 19, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR FIBRILLATION (VF) AND VENTRICULAR TACHYCARDIA (VT). THE DEVICE DELIVERED SHOCKS FOR BOTH. IT WAS SUSPECTED THAT THE RHYTHM FOR BOTH WAS ACTUALLY ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR), THEREFORE THE SHOCKS WERE INAPPROPRIATE. 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 16962996 ↗
• InjuryMay 4, 2023Adverse 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 EXTRACTED AND REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16868801 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN INFECTION. BLOOD CULTURES TESTED POSITIVE AND WOUND CULTURES WERE NEGATIVE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 16322398 ↗
• MalfunctionJan 17, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THEY WERE UNABLE TO GET AN ELECTROCARDIOGRAM (EKG), IT IS BELIEVED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS FAILING TO CAPTURE. 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 16184562 ↗
• MalfunctionMay 7, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC) DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). THE EMI ALSO PRESENTED AS NOISE ON BOTH ATRIAL AND VENTRICULAR CHANNELS WITH NO EVIDENCE OF A LEAD ISSUE. 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 14316984 ↗
• InjuryMar 19, 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) SYSTEM WAS EXPLANTED DUE TO A INFECTION. CULTURES WERE TAKEN, AND THE PATIENT WAS TREATED WITH ANTIBIOTICS. A NEW SYSTEM WAS IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9856612 ↗
• MalfunctionMar 18, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A GREY BAR FOR BATTERY LONGEVITY PRIOR TO IMPLANT. THE DEVICE WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9850009 ↗
• MalfunctionMar 11, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED, AND THE LONGEVITY BAR WAS GRAY INSTEAD OF GREEN. THE ICD WAS NOT USED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9821914 ↗
• MalfunctionNov 11, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PHYSICIAN HAD PROBLEMS SECURING THE LEAD. THE SET SCREW WAS INDICATED TO HAVE BEEN BACKED OUT TOO MUCH. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9305543 ↗
• InjuryOct 1, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED 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 9140859 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TWENTY-ONE DAYS POST GENERATOR CHANGE OUT THAT THE PATIENT APPEARED TO HAVE AN INFECTED DEVICE POCKET. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. THE PATIENT WAS PUT ON ANTIBIOTICS. IT WAS NOTED THAT THE PATIENT IS WEARING A LIFE VEST WHILE THEY HEAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9072268 ↗
• MalfunctionMar 27, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO IMPLANT THE DEVICE DISPLAYED A "GRAY BAR" BATTERY LONGEVITY INDICATING A LOW TELEMETRY BATTERY VOLTAGE ISSUE. THE DEVICE WAS ATTEMPTED TO BE USED AGAIN AT A LATER DATE AND THE BATTERY HAD NOT RECOVERED. THE DEVICE WAS NOT UTILIZED AND NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8458056 ↗
• MalfunctionMar 26, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD GRAY BAR FOR LONGEVITY ESTIMATE. IT WAS NOTED THAT THE DEVICE WAS NEVER OPENED AND WAS NOT USED FOR ANY CASE. THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8452996 ↗
• MalfunctionMar 21, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT ATTEMPT, THE SETSCREW COULD NOT BE ENGAGED. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8442357 ↗
• MalfunctionFeb 25, 2019Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED AND DURING INDUCTION TESTING POST-OPERATIVE A SCREEN DISPLAYED "NO INDUCTIONS PERFORMED DURING CURRENT SESSION" WHEN THE FIELD REPRESENTATIVE TRIED TO RETRIEVE DATA AFTER COMPLETING INDUCTION TESTING. IT WAS NOTED THE DEVICE DETECTED, AND SUCCESSFULLY TREATED DURING THE INDUCTION AND THE DEVICE FUNCTIONALITY WAS NORMAL. 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 8368218 ↗