Solara™ CRT-P MRI SureScan™ W1TR03 (UDI 00643169891449)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00643169891449), received between Jul 5, 2018 and Sep 25, 2026 — classified as 1 death, 36 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced twiddlers syndrome. The Implantable Pulse Generator (IPG) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50895376 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a pocket infection. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50771333 ↗
• InjuryAug 20, 2026Device Sensing Problem

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave oversensing and the Cardiac Resynchronization Therapy Pacemaker (CRT-P) exhibited a detection issue. The RV lead and CRT-P 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 50343372 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE "FAINTED AND WAS TAKEN TO THE EMERGENCY ROOM". THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25218421 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT  THE PATIENT WAS PICKING AT THE INCISION WITH THEIR FINGERNAILS AND THEY GOT AN INFECTION. THE PATIENT ALSO EXPERIENCED EROSION AND PURULENT DISCHARGE/PUS. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE IMPLANTABLE PULSE GENERATOR IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Medical device site infection; Purulent Discharge

  MAUDE report 24454000 ↗
• InjuryFeb 16, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE TRICUSPID VALVE REGURGITATION DUE TO RIGHT VENTRICULAR ENDOCARDIAL LEAD IMPINGEMENT. THE TRICUSPID REGURGITATION RESULTED IN CONGESTIVE HEART FAILURE. THE PATIENT HAD VERY MINIMAL SUBCUTANEOUS FAT IN THEIR CHEST CAUSING THE IMPENDING PERFORATION OF THE DEVICE AT THE COMERS OF THE GENERATOR. THE BI-VENTRICULAR PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 24344322 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS NOTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 23768429 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY FIVE MONTHS POST IMPLANT THAT THE PATIENT DEVELOPED A POCKET INFECTION WITH SYMPTOMS OF PAIN, PURULENT DISCHARGE, REDNESS, HEAT, AND WOUND DEHISCENCE. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Pain; Purulent Discharge; Wound Dehiscence

  MAUDE report 23495344 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. FATIGUE, FEVER AND PUS AT THE POCKET SITE WERE OBSERVED. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue; Fever; Unspecified Infection

  MAUDE report 22991360 ↗
• InjuryMay 29, 2025Adverse 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 THEY DEVELOPED AN INFECTION FOLLOWING A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) CHANGEOUT PROCEDURE. THE CRT-P SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22110423 ↗
• MalfunctionMay 1, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS FURTHER REPORTED THAT ELECTROMAGNETIC INTERFERENCE WAS CONFIRMED, AND OBSERVED DURING PULMONARY VEIN ISOLATION (PVI), POSTERIOR WALL ISOLATION (PWI), AND ANTERIOR MITRAL LINE ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941179 ↗
• MalfunctionMar 20, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)'S LOWER RATE LIMIT WAS SUPPOSED TO BE PROGRAMMED TO SEVENTY BEATS PER MINUTE BUT AT NIGHT, THE PATIENT'S HEART RATE WOULD DIP DOWN TO FIFTY BEATS PER MINUTE. THE PATIENT CONTINUED, "DURING THE DAY IT WILL TAKE CARE OF IT, IT WILL GO INTO THE ONE-HUNDREDS". THE PATIENT STATED THAT THEY RECOGNIZED THIS PATTERN AFTER WEARING THEIR SMART WATCH ON AND OFF. THE PATIENT STATED, "ACCORDING TO THE WATCH, IT STAYS THERE MOST OF THE NIGHT AND THEN IT BOUNCES BACK". ADDITIONALLY, THE PATIENT NOTED THAT THEIR PHYSICIAN SAID THAT THEY "THROW A LOT OF PREMATURE VENTRICULAR CONTRACTIONS (PVC)". THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21654391 ↗
• InjuryMar 5, 2025Premature Discharge of Battery; Pacing Problem; Premature Discharge of Battery; Pacing Problem

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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 21529806 ↗
• MalfunctionFeb 20, 2025High impedance; Mechanical Problem; High impedance; Mechanical Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE WHEN THE RIGHT VENTRICULAR (RV) LEAD WAS INSERTED INTO THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HEADER AND THE SETSCREW WAS TIGHTENED THERE WAS A HIGH UNDEFINED RV LEAD IMPEDANCE MEASUREMENT OBSERVED. THE SETSCREW WAS LOOSENED AND AN ATTEMPT TO INSERT THE RV LEAD FURTHER INTO THE HEADER WAS ATTEMPTED. THE RV LEAD WAS REMOVED FROM THE CRT-P HEADER AND THE LEAD PIN WAS CLEANED AND REINSERTED INTO THE HEADER. THE CRT-P SETSCREW WAS ENGAGED AND NO CLICKING SOUND WAS HEARD. IT WAS NOTED THAT THE SETSCREW FELT LIKE IT WAS "JUST SPINNING". THE CRT-P WAS REPLACED WITH A NEW DEVICE AND THE RV LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21423465 ↗
• MalfunctionNov 27, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT WHEN THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS PROGRAMMED AND TURNED ON PROPERLY THEY STARTED DYING. THE PATIENT NOTED THAT THEY DIDN'T THINK THEY NEEDED THE DEVICE AND THAT FOR TWENTY-ONE YEARS THE DEVICE HAS NOT WORKED FOR THEM. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20799453 ↗
• InjuryNov 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND A LOSS OF CONSCIOUSNESS. IT WAS NOTED THAT THE PATIENT HEART RATE DROPPED TO THE THIRTIES. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Loss of consciousness; Syncope/Fainting

  MAUDE report 20712385 ↗
• InjurySep 18, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-P WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. THE HIS BUNDLE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252182 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A FUNGAL INFECTION ON THE IMPLANTED LEADS. VEGETATION WAS OBSERVED ON THE LEADS, AND THE INFECTION SOURCE WAS IDENTIFIED AS A STRAIGHT CATH. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) 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: Unspecified Infection

  MAUDE report 20028949 ↗
• InjuryAug 14, 2024Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIGHTHEADEDNESS AND SHORTNESS OF BREATH. LOSS OF CAPTURE WAS SEEN ON A HOLTER MONITOR. IT WAS NOTED THIS WAS DUE TO THE DEVICE FEATURE THAT MONITORS THE PACING AMPLITUDE THRESHOLD AND ADJUSTS LEAD OUTPUT RUNNING. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE REPROGRAMMING HAD BEEN PERFORMED, AND THE DEVICE FEATURE WAS WAS PROGRAMMED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 19981488 ↗
• InjuryAug 9, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT POST DEVICE IMPLANT, THE BATTERY VOLTAGE WAS LESS THAN EXPECTED. IT WAS DETERMINED THAT THE DEVICE HAD BEEN EXPOSED TO A MAGNET SOURCE PRIOR TO IMPLANT FOR OVER TWO THOUSAND HOURS, CREATING A FOUR YEAR DECREASE TO THE DEVICE LONGEVITY. 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 19949746 ↗
• InjuryAug 6, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE DUE TO FRACTURE. THE RV AND LV LEADS WERE CAPPED AND REPLACED. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921522 ↗
• MalfunctionJul 2, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) LEADS ALL HAD ELEVATED OUTPUTS. THE CLINICIAN INQUIRED IF THE HIGH OUTPUTS WERE CAUSING UNEXPECTED DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BATTERY. THE CRT-P AND LEADS 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 19660175 ↗
• InjuryJun 25, 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) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER DUE TO AN INFECTION. IT WAS NOTED THAT A PIN PLUG ERODED THROUGH THE DEVICE POCKET AT THE INCISION LINE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19605842 ↗
• MalfunctionJun 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO BRADYCARDIA. IT WAS NOTED THAT THE PATIENT SUSPECTED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING CORRECTLY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 19521466 ↗
• MalfunctionApr 2, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXPERIENCE ELECTROMAGNETIC INTERFERENCE THAT PRESENTED AS INTERMITTENT OVERSENSING ON STORED EPISODES. THE CRT-P 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 19028702 ↗

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-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-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-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-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• 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-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-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-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-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.