Evera™ XT DR DDBB1D4 (UDI 00643169929128)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169929128), received between Feb 8, 2018 and Apr 3, 2026 — classified as 10 injuries, 7 malfunctions.

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

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD RESULTING IN UNNECESSARY PACING. IT WAS ALSO NOTED THERE WAS POSSIBLE INAPPRORPIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR FIBRILLATION (VF). THE LEAD AND DEVICE 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 24777756 ↗
• InjuryOct 17, 2024Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY AND A SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 20472633 ↗
• MalfunctionMay 1, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING FOR DETECTED VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WAS IN PROGRESS AT THE TIME OF THERAPY. 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 19220104 ↗
• MalfunctionApr 11, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSING WAS NOTED DURING LEAD IMPEDANCE MEASUREMENT TESTS BY 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 19092926 ↗
• MalfunctionSep 29, 2022Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT'S HEART RATE OF 44 BEATS PER MINUTE OBSERVED ON HOSPITAL TELEMETRY FOR ABOUT 30 MINUTES WAS NOT RELATED TO A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OR RIGHT VENTRICULAR (RV) LEAD PRODUCT PERFORMANCE ISSUE. IN ADDITION, THE RV LEAD WAS REPROGRAMMED.

  Patient problems: Bradycardia

  MAUDE report 15503120 ↗
• MalfunctionDec 21, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). IT WAS NOTED THAT ALL WERE RECORDED DURING SURGERY AS THE MAGNET HAD NOT BEEN PROPERLY PLACED. IT WAS FURTHER REPORTED THAT ATRIAL BLANKED EVENTS CONSISTENT WITH RIGHT ATRIAL (RA) LEAD FAR FIELD R-WAVE (FFRW) OVERSENSING WERE OBSERVED. TROUBLESHOOTING WAS ATTEMPTED; HOWEVER, FFRW WAS STILL OBSERVED. NO ADJUSTMENTS WERE ULTIMATELY MADE, AND THE RA LEAD REMAINS IN USE. 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 13052885 ↗
• InjuryNov 15, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED MULTIPLE INAPPROPRIATE THERAPIES DUE TO DETECTING ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) FOLLOWED BY RAPID VENTRICULAR RESPONSE (RVR) AS VENTRICULAR FIBRILLATION (VF). IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS NON-COMPLIANT WITH MEDICATIONS. 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 12817403 ↗
• InjurySep 27, 2021Inappropriate/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 SYNCOPE AND RECEIVING A SHOCK FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). A REMOTE MONITORING TRANSMISSION INDICATED THE PATIENT WAS TREATED FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF) BUT THE RHYTHM WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE SHOCK WAS SUSPECTED TO BE INAPPROPRIATE. ADDITIONALLY, POSSIBLE UNDERSENSING WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. BOTH THE 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); Syncope/Fainting

  MAUDE report 12533480 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT REPROGRAMMING OCCURRED.

  Patient problems: Tachycardia

  MAUDE report 12461499 ↗
• InjuryApr 12, 2021Adverse 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. AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED AT A LATER TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11653264 ↗
• InjuryMar 20, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A POSSIBLE INAPPROPRIATE SHOCK DUE TO ATRIAL TACHYCARDIA. 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 9859856 ↗
• MalfunctionJan 3, 2020Failure to Capture; Failure to Capture

  IT WAS REPORTED APPROXIMATELY SEVEN MONTHS POST IMPLANT THE DEVICE IS PACING BUT DID NOT APPEAR TO BE CAPTURING. 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 9546765 ↗
• InjurySep 4, 2019Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT A REMOTE TRANSMISSION SHOWED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR A VENTRICULAR FIBRILLATION (VF) CLASSIFIED EVENT THAT APPEARED TO BE AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE. IN ADDITION, THERE APPEARED TO BE OVERSENSING NOISE ON THE ATRIAL CHANNEL THAT WAS SIMILAR TO ELECTROMAGNETIC INTERFERENCE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) AND ATRIAL LEADS BOTH HAD PAST HIGH THRESHOLD MEASUREMENTS. THE ICD AND LEADS 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 8960626 ↗
• MalfunctionFeb 27, 2019Electrical /Electronic Property Problem; Battery Problem; Electrical /Electronic Property Problem; Battery Problem

  IT WAS REPORTED THAT PRIOR TO IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INTERROGATED A ¿GRAY BAR¿ STATUS INDICATING THAT THE BATTERY VOLTAGE LEVEL IS NOT ACCEPTABLE FOR IMPLANT. THE DEVICE BATTERY LONGEVITY WAS LESS THAN EXPECTED. THE DEVICE WAS NOT USED FOR IMPLANT. THERE WERE NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8372747 ↗
• MalfunctionFeb 25, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED GRAY BAR PRIOR TO ATTEMPTING TO IMPLANT THE DEVICE. THE ICD WAS NOT USED AND REPLACED BY A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367209 ↗
• InjuryApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7466013 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD GENERAL NECK SWELLING, DIFFICULTY BREATHING, AND POSSIBLE HYPERSENSITIVITY AFTER THEIR ABSORBABLE ANTIBACTERIAL ENVELOPE (AAE) WAS IMPLANTED, INTUBATION WAS NECESSARY. THE AAE WAS EXPLANTED AND REPLACED WITH A NEW AAE. APPROXIMATELY FIFTEEN MINUTES AFTER THE PATIENT'S POCKET WAS CLOSED THEY HAD GENERAL THROAT SWELLING AND SOME DIFFICULTY BREATHING. FIVE DAYS LATER, AFTER EVALUATION, THE SECOND AAE WAS EXPLANTED. IT WAS ALSO REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA AFTER THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED. FOUR DAYS AFTER THE ICD WAS IMPLANTED, THE POCKET WAS REOPENED AND THE HEMATOMA WAS EVACUATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 7254391 ↗