SelectSecure™ MRI SureScan™ 383059 (UDI 00763000130794)Recalls & reported problems

Summary

The FDA's MAUDE database contains 574 adverse event reports that list this exact device (DI 00763000130794), received between Feb 5, 2019 and Sep 24, 2026 — classified as 18 deaths, 274 injuries, 282 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (207 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 574 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Retraction Problem

  It was reported that the Right Ventricular (RV) lead was explanted and replaced due to falling RV Pacing impedance and variable impedance. It was reported that the Right Atrial (RA) lead was because it was causing a difficult access point to remove the RV lead. Once the RA lead was extracted the RV lead was extracted easily. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884028 ↗
• MalfunctionSep 18, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828545 ↗
• MalfunctionSep 18, 2026Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited oversensing that does not appear to be affecting device function. The RA lead 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 50813989 ↗
• MalfunctionSep 11, 2026Device Sensing Problem; Unstable Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited variability in P wave amplitude and variability in capture threshold on current and stored electrograms (EGM). The RA lead remains in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731518 ↗
• MalfunctionAug 26, 2026Under-Sensing; Decreased Sensitivity

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459766 ↗
• MalfunctionAug 18, 2026Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress. The RA lead remains in use. No patient complications havebeen reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295704 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced spinal osteomyelitis , Methicillin-sensitive Staphylococcus aureus and a fever. The Implantable Pulse Generator (IPG) system was explanted and then replaced six days later. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Fever; Unspecified Infection

  MAUDE report 50284000 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the emergency room with pocket erosion. The device was initially implanted very laterally and had progressively moved/migrated more laterally. The patient does a lot of movement and overhead and manual labor for their job and could feel the device rocking and flipping in the pocket. The patient had been seen several months prior at which time it was noted that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) site was adhering to the lateral aspect of the skin. The patient had declined a recommended pocket revision at the time. The system was removed. A new system was implanted several days later on the patient's opposite side. No further patient complications have been reported as a result of this event.

  Patient problems: Erosion

  MAUDE report 50153910 ↗
• InjuryJul 30, 2026Device Dislodged or Dislocated

  It was reported that the Right Ventricular (RV) lead exhibited dislodgement. The lead was explanted and replaced. No patient complic ations have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084203 ↗
• MalfunctionJul 13, 2026High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF STIMULATION FROM THE RIGHT VENTRICULAR LEFT BUNDLE BRANCH (RV-LBB) LEAD. THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH BUT STABLE THRESHOLDS. THE RA AND RV-LBB LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25793760 ↗
• MalfunctionJul 8, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT RESULTED IN UNNECESSARY PACING. THE RA LEAD 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 25749877 ↗
• MalfunctionJun 26, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CHEST PAIN AND A REVIEW OF STORED EPISODES IDENTIFIED INTERMITTENT UNDERSENSING ON THE ATRIAL LEAD, WHICH CONTRIBUTED TO MISCLASSIFICATION OF SOME EPISODE DETECTIONS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 25640442 ↗
• MalfunctionJun 26, 2026Degraded

  THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING PROPHYLACTICALLY REPLACED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25633545 ↗
• MalfunctionJun 18, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD 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 25548784 ↗
• MalfunctionJun 12, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES. THE LEAD 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 25488132 ↗
• MalfunctionJun 9, 2026Electrical /Electronic Property Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD FAILED AN ATRIAL LEAD POSITION CHECK AND EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS. THE LEAD 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 25440600 ↗
• MalfunctionMay 1, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD 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 25054781 ↗
• MalfunctionMay 1, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD 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 25054552 ↗
• InjuryApr 30, 2026Signal Artifact/Noise; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PREMATURE BATTERY DEPLETION. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND NOISE. THE ICD AND LEAD WERE 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 25049610 ↗
• MalfunctionApr 27, 2026Electrical /Electronic Property Problem; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED DIMINISHED SENSING AND FAILED A POSITION CHECK. THE LEAD 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 24998263 ↗
• MalfunctionApr 9, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND UNNECESSARY PACING. IT WAS ALSO REPORTED THAT RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD CAPTURE WAS UNABLE TO BE CONFIRMED ON SOME AT/AF EPISODES. THE RA LEAD AND THE RV 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 24827141 ↗
• MalfunctionApr 7, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND INAPPROPRIATE PACING. THE LEAD 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 24798418 ↗
• MalfunctionApr 2, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING ON STORED EPISODES TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE MISCLASSIFICATION. THE LEAD 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 24766905 ↗
• MalfunctionApr 2, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AND TERMINATION OF AT/AF DETECTED EVENTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765189 ↗
• MalfunctionMar 30, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND INAPPROPRIATE ATRIAL PACING. THE LEAD 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 24712437 ↗