Consulta® CRT-D D204TRMRecalls & reported problems
Medtronic, Inc. · CRT D204TRM CONSULTA CRT-D US MR DF4 · Class 3 · Implant
All models of Consulta CRT-D (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00613994714701), received between Apr 6, 2017 and Mar 9, 2020 — classified as 22 injuries.
The most frequently reported specific device problem is “Premature Discharge of Battery” (14 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
Device problems
- Premature Discharge of Battery14
- Adverse Event Without Identified Device or Use Problem2
- Delayed Charge Time2
- Mechanical Problem2
- Communication or Transmission Problem1
- Electrical /Electronic Property Problem1
- Failure to Charge1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- No Known Impact Or Consequence To Patient19
- Unspecified Infection2
- Endocarditis1
- Shock from Patient Lead(s)1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryMar 9, 2020Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING A DEVICE REPLACEMENT PROCEDURE A TELEMETRY SESSION COULD NOT BE ESTABLISHED WITH THE EXISTING CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE DEVICE WAS EXPLANTED AND REPLACED AS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9806844 ↗InjuryAug 28, 2018Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS DIFFICULT TO REMOVE FROM THE HEAD OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS NOTED THAT THE SET SCREW WOULD NOT LOOSEN TO ALLOW REMOVAL OF THE RV LEAD. THE PULLING FORCE OF THE OPERATOR CAUSED THE LEAD TO BE DAMAGED WHEN ATTEMPTING TO REMOVE FROM THE DEVICE. A TECHNICIAN WAS LATER ABLE TO MANIPULATE THE SET SCREW ENOUGH TO REMOVE THE DAMAGED LEAD FROM THE CRT-D. THE LEAD WAS CAPPED AND REPLACED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7823682 ↗InjuryJul 19, 2018Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7702878 ↗InjuryJul 5, 2018Failure to Charge; Failure to Charge
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED AN AUDIBLE ALERT FOR EXCESSIVE CHARGE TIME AND END OF SERVICE (EOS) WAS INDICATED AS WELL. IT WAS NOTED THAT THE DEVICE HAD BEEN BEING MONITORED EACH MONTH BECAUSE IT WAS APPROACHING RECOMMENDED REPLACEMENT TIME (RRT) - ONE MONTH EARLIER, THE DEVICE HAD STILL BEEN AT PRE-RRT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7663458 ↗InjuryJun 4, 2018Electrical /Electronic Property Problem; Delayed Charge Time; Electrical /Electronic Property Problem; Delayed Charge Time
IT WAS REPORTED THAT THE DEVICE HAD REACHED END OF SERVICE (EOS) DUE TO CHARGE CIRCUIT INACTIVE WITH CHARGE TIMES GREATER THAN 30 SECONDS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7567378 ↗InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE DEVICE AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 7459403 ↗InjuryApr 10, 2018Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY SHOCKED THE PATIENT DUE TO OVERSENSING OF NOISE. THE PATIENT WAS UNDERGOING SURGERY AND ELECTROCAUTERY WAS USED WITHOUT APPLYING A MAGNET TO THE DEVICE. THE DEVICE DETECTED THE ELECTROCAUTERY AS NOISE. 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 7415245 ↗InjuryDec 7, 2017Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NON-PHYSIOLOGIC OVERSENSING AND NOISE, WHICH TRIGGERED A LEAD INTEGRITY ALERT. A FRACTURE WAS DOCUMENTED, BUT THE PHYSICIAN SUSPECTED THERE MAY BE A DEVICE SET SCREW ISSUE. THE LEAD WAS CAPPED AND REPLACED, AND DURING THE REVISION, THE SET SCREWS FOR THE RV PORT AND ALSO THE LEFT VENTRICULAR PORT DID NOT SEEM TIGHT. A FAULTY HEADER WAS POSSIBLE SO THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7092544 ↗InjuryDec 7, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7092320 ↗InjuryAug 9, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6782565 ↗InjuryAug 9, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6781927 ↗InjuryAug 9, 2017Premature Discharge of Battery; Delayed Charge Time; Premature Discharge of Battery; Delayed Charge Time
IT WAS REPORTED THAT THE DEVICE INDICATED ELECTIVE REPLACEMENT (ERI), BUT THEN SUDDENLY AND PREMATURELY INDICATED END OF SERVICE (EOS) DUE TO LONG CHARGE TIME. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6781385 ↗InjuryAug 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED ENDOCARDITIS AND SUSPECTED BACTEREMIA. IT WAS ALSO REPORTED THAT EVIDENCE OF VEGETATION WAS FOUND IN THE PATIENT'S RIGHT ATRIUM ON ONE OF THE INTRACARDIAC LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 6779318 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6628239 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE DEVICE HAD ACCELERATED BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL, RIGHT VENTRICULAR, AND LEFT VENTRICULAR LEADS HAD REDUCED IMPEDANCE. THE LEADS REMAIN IN USE. THE PATIENT WAS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6627656 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6625932 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN IT SHOULD HAVE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6625923 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY MAY HAVE DEPLETED PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6624888 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6624749 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6624427 ↗InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6624305 ↗InjuryApr 6, 2017Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) AND UNEXPECTED LONGEVITY WAS SUSPECTED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6466800 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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