Consulta CRT-DRecalls & reported problems across all models

We found 2 models of Consulta CRT-D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 120 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Feb 28, 2024 — classified as 2 deaths, 103 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (36 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Consulta CRT-D problems

Consulta CRT-D models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Consulta® CRT-D D224TRK

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths98 reports
• Consulta® CRT-D D204TRM

  Implantable cardioverter defibrillator (non-CRT)
  22 reports

Recent Consulta CRT-D adverse event reports

The 15 most recent reports across all models, 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 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls