Evera™ XT DR DDBB1D1 (UDI 00763000059569)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00763000059569), received between Feb 8, 2018 and Apr 11, 2024 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).

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-1704-2023 · Root cause: Under Investigation by firm · FDA record ↗

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.

• InjuryApr 11, 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 REMOVED DUE TO INFECTION. THE SYSTEM WAS LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19087198 ↗
• 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 POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18941202 ↗
• InjuryJan 6, 2020Adverse 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 EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9555768 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXTRACTED DUE TO POCKET EROSION / INFECTION. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR PACING (VP) IMPACTING THE PACING RATE AND THE PATIENT IS PACEMAKER DEPENDENT. THE PATIENTS ICD SYSTEM WAS EXTRACTED AND A NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 9540295 ↗
• MalfunctionApr 18, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, PRIOR TO CONDUCTING DEFIBRILLATION THRESHOLD TESTING, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LONGEVITY ESTIMATOR TURNED GRAY. THE PHYSICIAN ELECTED NOT TO USE THE DEVICE, AND A NEW 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 8528915 ↗
• InjuryFeb 22, 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) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE ORGANISM WAS IDENTIFIED AS BACTEREMIA WITH CULTURES DEMONSTRATING STAPHYLOCOCCUS AUREUS. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8361856 ↗
• MalfunctionDec 20, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A POST-OPERATIVE CHECK, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED IMPEDANCE AND NOISE RESULTING FROM A SUSPECTED SUPERIOR VENA CAVA (SVC) COIL FRACTURE. THE PHYSICIAN SUSPECTED A LOOSE SETSCREW OF THE DEVICE AFTER THE RECENT GENERATOR CHANGE. THE SUPERIOR VENA CAVA (SVC) COIL WAS TURNED OFF AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 8184997 ↗
• InjuryApr 10, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FOLLOW-UP WAS ATTEMPTED WITH THE PHYSICIAN; HOWEVER, NO ADDITIONAL INFORMATION COULD BE OBTAINED. 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 7418214 ↗
• MalfunctionApr 10, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH AND UNDEFINED RV COIL DEFIBRILLATION IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. THE REPLACEMENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED HIGH AND UNDEFINED RV DEFIBRILLATION IMPEDANCE WHEN HOOKED UP TO THE REPLACEMENT RV LEAD. THE REPLACEMENT RV LEAD HAD NORMAL IMPEDANCE THROUGH THE OLD DEVICE. THE REPLACEMENT DEVICE WAS NOT USED AND A NEW 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 7416835 ↗
• InjuryApr 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POCKET INFECTION HAD OCCURRED. THE INCISION SITE HAD BEEN SLOW TO HEAL. THE PATIENT PICKED THE INCISION SCAB AND SHORTLY AFTER THE SITE BECAME RED AND SWOLLEN. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Impaired Healing; Swelling; Unspecified Infection

  MAUDE report 7415362 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET WAS REVISED AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 7256934 ↗