SelectSecure™ MRI SureScan™ 383074 (UDI 00763000130817)Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00763000130817), received between Nov 8, 2019 and Feb 16, 2026 — classified as 1 death, 35 injuries, 15 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (15 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 51 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE 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 24343562 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEFT BUNDLE BRANCH (LBB) RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 22978785 ↗
• MalfunctionSep 3, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE PHYSICIAN WANTED TO REVISE THE LEAD TO IMPROVE DEVICE BATTERY LIFE. A NEW LV LEAD WAS ATTEMPTED TO BE IMPLANTED, BUT DUE TO PATIENT ANATOMY, A NEW LEAD COULD NOT BE IMPLANTED. A NEW LEAD WAS EVENTUALLY IMPLANTED IN THE LEFT BUNDLE BRANCH AREA. THE CHRONIC LV LEAD WAS THEN PLUGGED INTO THE NEW DEVICE AND INACTIVATED. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A MEASUREMENT OF HIGH THRESHOLD. THE RV 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 22956728 ↗
• InjuryMay 19, 2025Intermittent Capture; Failure to Capture; Unstable Capture Threshold; Intermittent Capture; Failure to Capture; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Fall; No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 22042279 ↗
• MalfunctionMar 10, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED DURING IMPLANT OF THE PACING LEAD THAT THE LEAD SCREW TIP BENT WHEN THE PHYSICIAN WAS PLACING THE LEAD. THE LEAD WAS ATTEMPTED/ NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559542 ↗
• InjuryFeb 20, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. THE 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 21419844 ↗
• MalfunctionFeb 7, 2025Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  IT WAS FURTHER REPORTED THAT THE SCREW TIP WAS BENT. THE LEAD WAS ATTEMPTED/NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21332959 ↗
• DeathFeb 3, 2025Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS FURTHER REPORTED THAT BEFORE THE PATIENT PASSED, THE RV LEAD EXHIBITED A DROP IN THE R WAVE MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tachycardia

  MAUDE report 21297487 ↗
• InjuryJan 7, 2025Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold; Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED APPROXIMATELY THREE WEEKS POST IMPLANT THAT THE LEFT BUNDLE BRANCH (LBB) LEAD DISLODGED. IT WAS ALSO REPORTED THAT THE LBB LEAD DISPLAYED NO CAPTURE AND HIGH THRESHOLD. THE LBB LEAD WAS TURNED OFF, 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 21091988 ↗
• MalfunctionNov 21, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE LEFT BUNDLE BRANCH (LBB) LEAD THAT WAS PLUGGED INTO THE RIGHT VENTRICULAR (RV) PORT EXHIBITED POSSIBLE UNDERSENSING WITH FALSE TERMINATION OF ONGOING VENTRICULAR ARRHYTHMIA NOTED ON STORED EPISODES. 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 20750489 ↗
• InjuryNov 4, 2024Extracardiac stimulation; Capturing Problem; Extracardiac stimulation; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET STIMULATION AND DISCOMFORT. THE RIGHT VENTRICULAR (RV) LEFT BUNDLE BRANCH (LBB) LEAD EXHIBITED SUDDEN INCREASE IN THRESHOLD. THE RV LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Discomfort

  MAUDE report 20597646 ↗
• InjuryOct 16, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT BUNDLE BRANCH (LBB) RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LBB RV LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20461872 ↗
• InjurySep 24, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE BRANCH LEAD WAS NOT CAPTURING. THE RV LEAD 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 20289646 ↗
• InjuryAug 13, 2024Intermittent Capture; Capturing Problem; High Capture Threshold; Intermittent Capture; Capturing Problem; High Capture Threshold

  IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS FURTHER NOTED THAT THE RV LEAD WAS CAPPED AND REPLACED.

  Patient problems: Dizziness; Presyncope; Syncope/Fainting

  MAUDE report 19972236 ↗
• InjuryJun 11, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE WAS HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLDS. THE RV LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508525 ↗
• MalfunctionMar 26, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT T-WAVE OVERSENSING. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORT ED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979834 ↗
• MalfunctionMar 22, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED NOISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960062 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18956255 ↗
• MalfunctionFeb 2, 2024Pacing Problem; Under-Sensing; Capturing Problem; Pacing Problem; Under-Sensing; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INAPPROPRIATE PACING AND POSSIBLE CAPTURE ISSUES. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 18629556 ↗
• InjuryDec 20, 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 IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18362922 ↗
• InjuryOct 31, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR HIS BUNDLE (RV HIS) LEAD WAS NOT PACING THE APPROPRIATE PART OF THE PATIENT'S HEART. THE RV HIS LEAD 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 18038931 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS FOUND TO HAVE ENTEROCOCCAL L3-L4 DISCITIS AND ENTEROCOCCAI BACTERMIA. THE PATIENT WAS PUT ON AN INTRAVENOUS (IV) ANTIBIOTIC THERAPY. THE PATIENT HAD POSITIVE BLOOD CULTURES FOR INFECTIOUS ENDOCARDITIS AND STREPTOCOCCUS SANGUINOUS. THE LEAD WERE FOUND TO HAVE THICKENED AND FIBRINOUS DENSITIES WITH NO CLEAR VEGETATION.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 18019902 ↗
• MalfunctionJul 21, 2023Under-Sensing; Decreased Sensitivity; Under-Sensing; Decreased Sensitivity

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS. THE RV HIS BUNDLE LEAD EXHIBITED CHRONICALLY LOW R WAVES.

  Patient problems: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17369592 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND DEHISCENCE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Wound Dehiscence

  MAUDE report 17315259 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TWO MONTHS POST-IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM THAT THE PATIENT DEVELOPED POCKET INFECTION. CULTURES WERE TAKEN AND PATIENT WAS TREATED WITH ANTIBIOTICS. THE IPG SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17222683 ↗