Selectsecure™ 383069 (UDI 00643169279193)Recalls & reported problems

Summary

The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 00643169279193), received between Feb 3, 2017 and Jul 30, 2026 — classified as 1 death, 78 injuries, 21 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (42 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 100 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Capturing Problem

  It was reported that the Right Ventricular (RV) lead exhibited rising thresholds. The RV lead was inactivated and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085984 ↗
• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD RETURNED FOR ANALYSIS AND TESTED OUT-OF-SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012155 ↗
• InjuryApr 8, 2026Failure to Capture

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS DEACTIVATED AND LATER CAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813536 ↗
• InjuryJan 22, 2026Intermittent Capture; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE. IT WAS FURTHER NOTED THAT THE RV LEAD EXHIBITED VARIABLE AND HIGH THRESHOLDS. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24142920 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO A POSITIVE BLOOD CULTURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24036647 ↗
• MalfunctionJan 12, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH RATE EPISODES. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING THAT APPEARED TO BE ELECTROMAGNETIC INTERFERENCE (EMI)/ NOISE. THE RV LEAD AND IPG REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24034864 ↗
• InjuryJun 18, 2025Capturing Problem; Capturing Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22282089 ↗
• InjuryMay 13, 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 22009607 ↗
• InjuryApr 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH IMPEDANCES. THE RV 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 21924671 ↗
• InjuryMar 31, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT DURING A ROUTINE CHECK THE RIGHT VENTRICULAR (RV) LEAD OUTPUT WAS ADJUSTED DUE TO THE THRESHOLD BEING SLIGHTLY ELEVATED. IT WAS NOTICED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT CAPTURING AFTER THE ADJUSTMENT WAS MADE. THE PATIENT EXPERIENCED ASYSTOLE AND SYNCOPE AS A RESULT. THE RV LEAD WAS REPROGRAMMED BACK TO PREVIOUS AMPLITUDE AND THE PATIENT RECOVERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; Syncope/Fainting

  MAUDE report 21729480 ↗
• InjuryFeb 18, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. 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 21395324 ↗
• InjuryDec 3, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT A PATIENT EXPERIENCED DIZZINESS AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD. THE DEVICE CLINIC NOTED THE OVERSENSING ISSUE AND THE PHYSICIAN ADVISED PROGRAMMING THE DEVICE TO AOO MODE. DESPITE THE PROGRAMMING ADJUSTMENT, THE PATIENT CONTINUED TO EXPERIENCE DIZZINESS, WHICH WAS BELIEVED TO BE RELATED TO THE PROGRAMMING RATHER THAN THE OVERSENSING. THE LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 20829826 ↗
• InjuryJul 10, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE EXPLANT PROCEDURE OF THE LEFT VENTRICULAR (LV) LEAD, THE RIGHT VENTRICULAR (RV) LEAD FRACTURED. THE RV LEAD DISTAL PORTION REMAINS IN PATIENT AND THE PROXIMAL PORTION WAS PARTIALLY EXPLANTED. THE RV LEAD WAS ALSO REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708862 ↗
• InjuryJan 26, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. THE HIS 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 18585922 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S POCKET HAD A CYST ON IT. IT WAS NOTED THAT THE PATIENT EXPERIENCED EROSION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cyst(s); Pocket Erosion

  MAUDE report 18524904 ↗
• InjuryJan 11, 2024Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE AND HIGH OUT OF RANGE (OOR) IMPEDANCE. PRIOR TO THE EXTRACTION OF THE RV LEAD THE CORDAE TENDINAE WAS RUPTURED RESULTING IN TRICUSPID VALVE REGURGITATION AND THE RV LEAD FRACTURED. THE RV LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 18491253 ↗
• InjuryNov 23, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO NOTED THAT THE RV LEAD WAS REPROGRAMMED AND LEAD TRENDS APPEARED STABLE. HOWEVER, WHEN THE PATIENT WENT FOR A SECOND CLINIC THE RV LEAD EXHIBITED HIGH THRESHOLD VALUES. 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 18198107 ↗
• MalfunctionNov 21, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 18180741 ↗
• InjuryNov 14, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. 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 18129668 ↗
• InjurySep 18, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. THE RV 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 17764054 ↗
• MalfunctionAug 9, 2023High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE AND HIGH THRESHOLDS. THE RV LEAD REMANS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 17488004 ↗
• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH VEGETATIONS NOTED ON THE LEADS. 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: Unspecified Infection

  MAUDE report 16548216 ↗
• MalfunctionFeb 16, 2023Failure to Capture; Under-Sensing; High Capture Threshold; Failure to Capture; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND SUSPECTED LOSS OF CAPTURE. THE CURRENT ELECTROGRAMS (EGM) REVEALED ATRIAL PACED VENTRICULAR SENSE BEATS AND VENTRICULAR SENSING EPISODES WITH SUSPECTED ATRIAL UNDERSENSING. 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 16386063 ↗
• InjuryFeb 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE RV LEAD "WAS STUCK IN THE POCKET" DUE TO OCCLUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 16364161 ↗
• DeathJan 6, 2023Failure to Capture; Over-Sensing; High Capture Threshold; Failure to Capture; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE PATENT WAS HOSPITALIZED AFTER HAVING A CARDIAC ARREST. IT WAS FOUND THAT THE THE RIGHT VENTRICULAR (RV) LEAD HAD MULTIPLE INSTANCES OF LEAD INTEGRITY ALERTS (LIA) TRIGGERED BY HIGH RATE NON-SUSTAINED EPISODES, AND SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO NOTED THAT CAPTURE COULD NOT BE CONFIRMED ON THE RV LEAD, T-WAVE OVERSENSING (TWOS) POST VENTRICULAR PACE (VP). RV OVERSENSING. HIGH RV THRESHOLDS, AND HIGH ATRIAL LEAD THRESHOLDS, BOTH OF WHICH ARE CONSISTENT WITH HISTORIC MEASUREMENTS. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 16117950 ↗