Evera™ XT DR DDBB1D4 (UDI 00643169720374)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169720374), received between Apr 25, 2018 and Jan 17, 2024 — classified as 14 injuries, 6 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. How this data works · Data updated Oct 13, 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-1705-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS AN EPISODE WITH RIGHT ATRIAL (RA) LEAD UNDERSENSING. IT WAS FURTHER REPORTED THAT THE PATIENT WAS BROUGHT INTO THE CLINIC TO ASSESS ATRIAL SENSITIVITY AND TO DETERMINE IF A VENTRICULAR FIBRILLATION (VF) EPISODE TREATED WITH ANTI-TACHYCARDIA PACING THERAPY WAS TRUE VF OR AN ATRIAL DRIVEN ARRHYTHMIA. IN ADDITION, THE PATIENT EXPERIENCED BRADYCARDIA WITH HEART RATES BELOW THE PROGRAMMED LOWER RATE OBSERVED. THE RA LEAD WAS REPROGRAMMED BUT WHEN THE ATRIAL SENSING WAS CHANGED THERE WERE NO P WAVES AT THIRTY BPM. THE ATRIAL SENSITIVITY WAS ALSO LOWERED BUT THIS RESULTED IN FAR FIELD R-WAVE (FFRW) OVERSENSING, SO THE SENSITIVITY WAS CHANGED BACK TO THE PREVIOUS SETTING. THE RA LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18528212 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RIGHT VENTRICULAR (RV) LEAD INFECTION. THE RV LEAD WAS CAPPED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS ALSO REMOVED AND DOWNGRADED TO AN IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18299758 ↗
• InjuryFeb 22, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED MULTIPLE SHOCKS FOR A RHYTHM THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). HOWEVER, IT IS SUSPECTED THAT THE SHOCKS MAY HAVE BEEN INAPPROPRIATE AS THE ¿VENTRICULAR MORPHOLOGY IS NARROW COMPLEX, ONSET DOES NOT APPEAR TO BE SUDDEN, AND ATRIAL ARRHYTHMIA ONGOING AT SAME TIME.¿ THE LEAD 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 16419068 ↗
• InjuryJun 29, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PREMATURE BATTERY DEPLETION.  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 14854131 ↗
• InjuryMay 9, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS A SUSPECTED INAPPROPRIATE SHOCK FOR POSSIBLE RAPID VENTRICULAR RESPONSE (RVR). AN ATRIAL ARRHYTHMIA WAS IN PROGRESS AT TIME OF THERAPY, WHICH 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 14337574 ↗
• InjuryOct 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. FOLLOWING THE PROCEDURE, THE PHYSICIAN ELECTED TO UTILIZE THE DEVICE AS AN EXTERNAL PACER TAPED TO THE PATIENT¿S CHEST. THE DEVICE WAS LATER REMOVED, AND A COMPETITOR DEVICE WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12617248 ↗
• MalfunctionJan 25, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS, DURING EPISODES THAT WERE THOUGHT TO BE SINUS TACHYCARDIA OR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETERMINED TO BE VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THAT AN ALGORITHM WITHHELD THERAPY PER PROGRAMMING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 11226887 ↗
• InjurySep 11, 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 SYSTEMIC STAPH INFECTION. THE SYSTEM WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10521465 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ERODED. THE ICD IMPLANT SYSTEM WAS REMOVED AND A WEEK LATER, A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 10425883 ↗
• MalfunctionJul 6, 2020Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT HEARD SOLID CONTINUOUS TONES AT RANDOM TIMES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS INTERROGATED AND NO ALERTS HAD BEEN TRIGGERED. IT WAS THOUGHT THAT THE PATIENT HAD MAGNET EXPOSURE. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233189 ↗
• InjuryJun 11, 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 EXTRACTED DUE TO AN INFECTION. CULTURES WERE TAKEN AND ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10145777 ↗
• MalfunctionJan 23, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT UPON INITIAL INTERROGATION PRIOR TO IMPLANT, MULTIPLE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)S EXHIBITED A LONGEVITY BAR THAT WAS GRAY INSTEAD OF GREEN. THE ICDS WERE NOT USED. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9622810 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT SYSTEM WAS REMOVED DUE TO A POCKET INFECTION. THE ICD IMPLANT SYSTEM WAS DOWNGRADED AND A NEW IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED ON THE PATIENT'S OTHER SIDE.. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9356740 ↗
• InjuryJul 25, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT A REMOTE TRANSMISSION SHOWED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED POSSIBLE INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR FIBRILLATION THAT THE ICD CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD WAS UNDERSENSING DURING ATRIAL ARRHYTHMIA EPISODES CAUSING THE EARLY TERMINATION OF EPISODES. THE ICD AND ATRIAL 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 8828301 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS AFTER A SYSTEM UPGRADE THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE SYSTEM WAS REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8737102 ↗
• InjuryJun 19, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE BEEN INAPPROPRIATELY SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) 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 8711724 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEART ATTACK AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT PROVIDE THERAPY. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 8531864 ↗
• InjuryApr 5, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) BEEPS IN THE MORNING, AND IT HAS BEEN FOR SEVERAL DAYS. FOLLOW-UP WITH THE CLINIC REVEALED THAT THE PATIENT RECEIVED A SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 8486896 ↗
• MalfunctionJul 30, 2018Appropriate Device Problem Term/Code Not Available

  APPROXIMATELY A MONTH POST IMPLANT OF THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT REPORTED THAT THEY HAVE BEEN HAVING PROBLEMS. FOR SOME REASON THE RHYTHM IS OFF AND THEY HAVE HAD THESE FLUTTERS; VERY STRONG FLUTTERS FOR OVER A MINUTE. THE PATIENT THOUGHT THAT THE DEFIBRILLATOR WAS SUPPOSED TO TAKE CARE OF THAT. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined; No Known Impact Or Consequence To Patient

  MAUDE report 7732409 ↗
• MalfunctionApr 25, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THERE WAS A SETSCREW PROBLEM WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE SETSCREW WAS MISALIGNED IN THE HEADER AND THE PHYSICIAN WAS UNABLE TO ENGAGE THE SETSCREW WITH THE WRENCH AFTER SEVERAL ATTEMPTS. THE DEVICE WAS NOT IMPLANTED AND AN ALTERNATE DEVICE WAS UTILIZED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7462764 ↗