Consulta® CRT-D D224TRKRecalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00613994446626), received between Feb 9, 2017 and Feb 28, 2024 — classified as 2 deaths, 81 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (22 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO ESTABLISH TELEMETRY WITH THE REMOTE MONITOR. TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. THE CRT-D AND MONITOR 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 18797172 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED TWELVE DAYS LATER.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18716756 ↗
• MalfunctionFeb 9, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS LATER IDENTIFIED THAT THE DEVICE WAS A COMPETITOR PRODUCT AND AS SUCH WAS UNABLE TO BE INTERROGATED BY THE MANUFACTURER'S PROGRAMMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18678545 ↗
• InjuryNov 14, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS AT END OF SERVICE (EOS) AND COULD NOT BE INTERROGATED. DURING THE CRT-D CHANGE-OUT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS TESTED AND HAD HIGH PACING AND HIGH RV COIL IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED, AND THE CRT-D 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 18136364 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION.  A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17670775 ↗
• InjuryAug 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE AND LEADS WERE EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17663446 ↗
• MalfunctionAug 1, 2023Communication or Transmission Problem; Communication or Transmission Problem

  UPON FURTHER REVIEW IT HAS BEEN NOTED THAT THE CRT-D WAS NOT ACTIVE AT THE TIME OF THE REPORTED "UNABLE TO INTERROGATE THE DEVICE WITH MOBILE APPLICATION, MESSAGE INDICATED "DEVICE NOT FOUND" BUT RATHER THE DEVICE WAS A COMPETITOR PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435710 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 17033714 ↗
• InjuryApr 4, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT A DEFECTIVE LEAD RESULTED IN MORE OF A DRAW ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY THAN IF THE LEAD WIRE WAS NOT DEFECTIVE. THE DEVICE 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 16675358 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16186752 ↗
• InjuryAug 4, 2022Premature Discharge of Battery; Failure to Interrogate; Premature Discharge of Battery; Failure to Interrogate

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE BATTERY WAS DEAD AND THE DEVICE COULD NOT BE INTERROGATED.  A  MEDICAL MAGNET WAS RECOMMENDED FOR INTERROGATION.  THE CRT-D 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 15169207 ↗
• MalfunctionApr 21, 2022Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT OVERSENSING DUE TO LEAD-ON-LEAD INTERACTION WAS NOTED ON THE RIGHT VENTRICULAR (RV) PACE/SENSE LEAD WORKING IN CONJUNCTION WITH DEFIBRILLATION COILS OF A DIFFERENT RV LEAD. A LARGE NUMBER OF SHORT VENTRICULAR INTERVALS WERE ALSO NOTED. THE LEADS REMAIN IN USE. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), WHICH WAS NOTED TO BE AT END OF SERVICE (EOS), EXHIBITED A LONG CHARGE TIME, A CHARGE CIRCUIT TIMEOUT, AND AN INACTIVE CHARGE CIRCUIT. THE CRT-D 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 14173797 ↗
• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION ON THE ENTIRE RIGHT SIDE OF THEIR CHEST. A REPLACEMENT SYSTEM WAS IMPLANTED APPROXIMATELY SIX WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12847362 ↗
• InjurySep 20, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED POSSIBLE EARLY BATTERY DEPLETION. THE DEVICE 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 12502014 ↗
• MalfunctionMay 13, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS AT END OF SERVICE (EOS) AND EXPERIENCED A CHARGE CIRCUIT TIMEOUT. THE CRT-D 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 11820361 ↗
• InjuryApr 1, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  FOLLOW UP WITH THE PATIENT CLINIC REVEALED THE ONLY HIGH VOLTAGE THERAPY THE PATIENT RECEIVED WAS DEEM TO BE APPROPRIATE THERAPY.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11603133 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED. 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 11027623 ↗
• MalfunctionSep 24, 2020Failure to Charge; Protective Measures Problem; Failure to Charge; Protective Measures Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY VOLTAGE HAD REACHED END OF SERVICE (EOS), RESULTING IN THE CHARGE CIRCUIT TO TIMEOUT DUE TO AN EXTENDED CHARGE TIME. IT WAS FURTHER NOTED THAT THE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPIES WOULD NOT BE DELIVERED BECAUSE THE CHARGE CIRCUIT HAD INACTIVATED. THE CRT-D HAD PREVIOUSLY BEEN PROGRAMMED TO NO LONGER DELIVER ATP AND SHOCK THERAPIES AND NO FURTHER ACTION WAS TAKEN. THE CRT-D REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580589 ↗
• MalfunctionSep 18, 2020Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED BY THE MONITOR. THE CRT-D 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 10553737 ↗
• MalfunctionSep 8, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS BEING REPROGRAMMED FOR SURGERY AND IT WAS NOTED THAT THE BATTERY VOLTAGE WAS AT END OF SERVICE (EOS) AND EXHIBITED A WARNING FOR THE CHARGE CIRCUIT BEING INACTIVE. THE PHYSICIAN HAS NOT DECIDED IF THE CRT-D WILL BE REPLACED AND THE CRT-D 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 10502721 ↗
• InjuryJun 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT REPORTED THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE BATTERY WAS DOWN, AND THE LEFT VENTRICULAR (LV) LEAD WAS WEAK. THE DEVICE WAS REPLACED. THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153313 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION AND EROSION OCCURRED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 10049003 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION OCCURRED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. ADDITIONAL INFORMATION RECEIVED REQUESTED LIST OF MATERIALS IN PATIENT PRODUCTS THAT HAD BEEN EXPLANTED PREVIOUSLY AS THE PATIENT HAS A HISTORY OF ALLERGIES TO CERTAIN MATERIALS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9856716 ↗
• InjuryDec 6, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS SHOCKED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 9423957 ↗
• InjuryJul 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8818025 ↗