Solara CRT-P MRI SureScanRecalls & reported problems across all models

We found 2 models of Solara CRT-P MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 126 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2018 and Sep 25, 2026 — classified as 4 deaths, 80 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (28 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 Solara CRT-P MRI SureScan problems

Solara CRT-P MRI SureScan models

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

• Solara™ CRT-P MRI SureScan™ W1TR03

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  3 deaths76 reports
• Solara™ CRT-P MRI SureScan™ W1TR03

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 death50 reports

Recent Solara CRT-P MRI SureScan adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionJan 15, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IS INCORRECTLY PACING ON THE RIGHT SIDE. 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 24078324 ↗
• 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 ↗
• MalfunctionNov 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552527 ↗
• 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 ↗
• InjuryOct 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE IS AT ELECTIVE REPLACEMENT INDICATOR (ERI).  MODE SET TO VVI/65 BPM, ALL ATRIAL TACHYCARDIA/ATRIAL F IBRILLATION (AT/AF) THERAPIES SET TO OFF. THE PATIENT  IS REPORTING PALPITATIONS, CLINICIAN REPORTING SHE SEES RHYTHM CHANGES ON THE TELE WHEN PATIENT IS HAVING PALPITATIONS. THE DEVICE WAS REPROGRAMMED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 23309027 ↗
• 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 ↗
• InjuryApr 21, 2025Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876205 ↗

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