Consulta® CRT-P C4TR01Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00613994713667), received between Oct 6, 2016 and Aug 28, 2025 — classified as 4 deaths, 107 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (41 reports).

10 other recalls cover devices cleared under the same FDA submission (P010015); they may or may not involve this specific model.

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

Recent adverse event reports

The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA. ENTEROCOCCUS WAS IDENTIFIED TO BE THE ORGANISM OF THE INFECTION. VEGETATION ON THE AORTIC VALVE WAS ALSO NOTED. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 22910853 ↗
• InjuryJun 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED NON-PROPHYLACTICALLY WHEREBY THE PHYSICIAN CLAIMS THE DEVICE WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318345 ↗
• MalfunctionFeb 12, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD APPROXIMATELY TEN SECONDS OF SENSED EVENTS BELOW THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21367427 ↗
• MalfunctionFeb 6, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. ADDITIONALLY, IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZA TION THERAPY PACEMAKER (CRT-P) EXHIBITED OCCASIONAL INAPPROPRIATE ATRIAL PACING. THE DEVICE AND LEAD 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 21323533 ↗
• InjuryDec 10, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS A "TEN YEAR DEVICE AND ONLY LAST SEVEN AND A HALF YEARS." THE CRT-P 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 20897211 ↗
• MalfunctionNov 18, 2024Premature Discharge of Battery; Communication or Transmission Problem; Premature Discharge of Battery; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY FEEL THAT THE BATTERY OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IS AT THE END AND IS WEARING OUT QUICKER.  THE PATIENT REPORTED THAT THE CLINIC WAS UNABLE TO RECEIVE TRANSMISSION REPORTS CURRENTLY.  THE DEVICE 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 20708767 ↗
• InjurySep 19, 2024Failure to Interrogate; Battery Problem; Capturing Problem; Failure to Interrogate; Battery Problem; Capturing Problem

  IT WAS FURTHER REPORTED ATTEMPTED TO INTERROGATE THE DEVICE MULTIPLE TIMES, BUT IT APPEARS TO HAVE BEEN END OF SERVICE (EOS) FOR A LONG TIME AND FINALLY RAN ITS COURSE.

  Patient problems: Bradycardia

  MAUDE report 20257025 ↗
• InjuryAug 20, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) POCKET WAS REVISED DUE TO PATIENT DISCOMFORT. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 20003827 ↗
• InjuryJul 24, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PRESSURE AND SHORTNESS OF BREATH.  IT WAS ALSO REPORTED THAT DURING USE OF THE RIGHT ATRIAL (RA) LEAD ATRIAL EVENTS APPEARED TO BE FALLING IN REFRACTORY PERIOD AT TIMES, POSSIBLY LEADING TO SOME INAPPROPRIATE ATRIAL PACING DURING ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EPISODES.  THE RA LEAD REMAINS IN USE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Dyspnea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19820451 ↗
• MalfunctionJul 11, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS UNABLE TO BE INTERROGATED AND A TRANSMISSION COULD NOT BE SENT. THE DEVICE 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 19726827 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION AND EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED, AND THE LEFT VENTRICULAR (LV) EPICARDIAL LEADS WERE PARTIALLY EXPLANTED. A TEMPORARY PACING LEAD WAS IMPLANTED, AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS LATER IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 19639372 ↗
• InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR POSSIBLE SYSTEM EXTRACTION; HOWEVER, THE EXTRACTION DID NOT OCCUR.

  Patient problems: Unspecified Infection

  MAUDE report 19579422 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED DUE TO INFECTION WITH NOTED FEVER, AND RIGHT VENTRICULAR (RV) LEAD VEGETATION.  THE ORGANISM WAS IDENTIFIED AS POSSIBLY METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS.  A TEMPORARY PACING SYSTEM WAS IMPLANTED.  A FEW DAYS LATER THE TEMPORARY PACING SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG).   NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Fever; Unspecified Infection

  MAUDE report 19371051 ↗
• InjuryJan 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE EXPERIENCING PAIN AND THEIR SKIN WAS PROTRUDING FROM THE DEVICE. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED AND THE DEVICE WAS REPLACED WITH A COMPETITOR PRODUCT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 18592136 ↗
• DeathDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE MANUFACTURER "MURDERED" THE PATIENT'S SPOUSE. ADDITIONAL INFORMATION RECEIVED NOTED THAT APPROXIMATELY FOUR MONTHS POST IMPLANT THE PATIENT WAS HOSPITALIZED FOR FLESH EATING BACTERIA IN A LEG WOUND. MULTIPLE SURGERIES WERE PERFORMED TO REMOVE THE INFECTION AND DEBRIDE NECROTIC TISSUE AND THE PATIENT PASSED AWAY TWO WEEKS LATER.

  Patient problems: Bacterial Infection

  MAUDE report 18252092 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE DURING A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REPLACEMENT PROCEDURE WHEN THE DEVICE WAS REMOVED FROM THE POCKET AS THE PATIENT WAS PROGRAMMED UNIPOLAR. THE DEVICE WAS PUT BACK IN THE POCKET AND THE PATIENT WAS PACED TO FACILITATE THE REPLACEMENT. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AT THIS TIME. THE LEAD WAS REPROGRAMMED TO A HIGH OUTPUT DUE TO THE POTENTIAL IMPEDANCE-RELATED LEAD INTEGRITY ISSUE AND REMAINED IN USE. THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY FIVE WEEKS LATER WITH ASYSTOLE, DIZZINESS, PRE-SYNCOPE, SHORTNESS OF BREATH,AND A FAILURE OF THE RV LEAD TO CAPTURE. THE PATIENT HAD REPORTEDLY NOT FELT WELL SINCE THE DEVICE REPLACEMENT. THE RV LEAD WAS STILL EXHIBITING LOW IMPEDANCE IN ADDITION TO OVERSENSING. THE PATIENT WAS TEMPORARILY PACED EXTERNALLY DUE TO THE RV CAPTURE ISSUES. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM A FEW DAYS LATER. UPON INVESTIGATION AFTER OPENING THE POCKET, THE LEADS APPEARED TO BE

  Patient problems: Asystole

  MAUDE report 18057645 ↗
• InjuryAug 31, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS FURTHER REPORTED THAT THE CRT-P WAS EXPLANTED AND REPLACED AFTER REACHING NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663116 ↗
• InjuryMay 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED NON-PROPHYLACTICALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16987112 ↗
• InjuryMay 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 PACEMAKER (CRT-P) SYSTEM WAS REMOVED DUE A BACTEREMIA INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 16843029 ↗
• MalfunctionApr 28, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS NOT PACING. THE DEVICE 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 16837323 ↗
• InjuryFeb 8, 2023Adverse 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 PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16330055 ↗
• MalfunctionJan 4, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE EXPERIENCING AN SLOWER HEART RATE AROUND 48 TO 52 BPM (BEATS PER MINUTE) AND THEY WERE "FEELING KIND OF ICKY". THE PACING RATE IS BELOW THE LOWER PROGRAMED SETTING OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE PATIENT INQUIRED IF THE BATTERY WAS LOW. THE CRT-P REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 16096131 ↗
• InjuryDec 16, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT CAUTERY AT THE BEGINNING OF A GENERATOR CHANGE PROCEDURE RESULTED IN AN OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENT AND A RV LEAD POLARITY SWITCH TO UNIPOLAR. AFTER THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BEING REPLACED WAS BROUGHT OUT OF THE POCKET AND THE LV LEAD WAS DISCONNECTED, ASYSTOLE OCCURRED BECAUSE THE RV LEAD WAS NOT CAPTURING. IT ALSO NOTED THAT INTERMITTENT PACING SPIKES SHOWED UP ON THE ELECTROCARDIOGRAM (ECG) STRIP BECAUSE THE CRT-P CAN WAS INTERMITTENTLY TOUCHING THE POCKET. THE CRT-P WAS SUCCESSFULLY REPLACED AND THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 15996228 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION OCCURRED. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND LEAD WERE EXPLANTED AND 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 14619529 ↗
• MalfunctionMay 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND WAS SHAKING. IT WAS FURTHER REPORTED THAT AN ELECTROCARDIOGRAM (EKG) SHOWED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS FAILING. THE CRT-P REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Shaking/Tremors

  MAUDE report 14453431 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010015. One submission often covers many models, so check the product and lot details in each record.

• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• Z-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• Z-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• Z-2413-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-2414-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-2412-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-2415-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.