SELECTSECURE™ 383069 (UDI 00885074407968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 00885074407968), received between Feb 9, 2017 and Sep 1, 2026 — classified as 4 deaths, 66 injuries, 58 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (35 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 128 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539527 ↗
• MalfunctionAug 26, 2026Pacing Problem; Under-Sensing

  It was reported that the Right Atrial (RA) lead exhibited under sensing resulting in misclassification of episode type, unnecessary pacing at times and termination of Atrial Tachycardia (AT)/Atrial Fibrillation (AF) detected event(s) in progress. It was reported that the Right Ventricular (RV) lead exhibited under sensing resulting in over pacing. It was reported that the RV lead was under sensing in blanking, resulting in over pacing. The Implantable Pulse Generator (IPG) system 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 50450814 ↗
• DeathJun 29, 2026Failure to Capture; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD BOTH EXHIBITED NO CAPTURE. THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED HIGH THRESHOLDS AND A RISE IN IMPEDANCE. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25649214 ↗
• InjuryMay 28, 2026Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH RV COIL IMPEDANCE AND HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NO CAPTURE. ADDITIONALLY, IT WAS REPORTED THAT THE RV PACE/SENSE LEAD EXHIBITED RISING THRESHOLDS. THE RV LEAD, LV LEAD AND RV PACE/SENSE LEAD WERE EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319858 ↗
• InjuryApr 16, 2026Intermittent Capture; High impedance; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND VARIABLE IMPEDANCE AS WELL AS INTERMITTENT CAPTURE. IT WAS FURTHER REPORTED THAT THE RA LEAD ALSO EXHIBITED VARIABLE IMPEDANCE. THE LEADS WERE REPROGRAMMED AND 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 24894124 ↗
• MalfunctionFeb 17, 2026Degraded

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD WERE RETURNED FOR AN UNKNOWN LEAD REASON, ANALYZED 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 24363546 ↗
• MalfunctionFeb 10, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, OVERSENSING AND A HIGH NUMBER OF SHORT V-V INTERVALS. 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 24302624 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT NO PERFORMANCE ISSUES WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289295 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG) THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT, HAD SOME REDNESS AND SWELLING. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND A TEMPORARY LEAD WAS IMPLANTED AND USED WITH THE DEVICE EXTERNALLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Swelling/ Edema

  MAUDE report 22907333 ↗
• InjuryJul 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN EXTRACTION PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS INADVERTENTLY DISLODGED. THE 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 22477996 ↗
• InjuryMay 21, 2025Intermittent Capture; High impedance; Intermittent Capture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE AND INTERMITTENT CAPTURE. 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 22058723 ↗
• MalfunctionMay 16, 2025High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE, OVERSENSING AND SHORT V-V INTERVALS. 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 22033839 ↗
• MalfunctionMar 28, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED INCREASED OUTPUT THROUGH CAPTURE MANAGEMENT PRECEDING THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGER, WHICH SUBSEQUENTLY TURNED OFF THE RIGHT VENTRICULAR CAPTURE MANAGEMENT (RVCM). 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 21718323 ↗
• InjuryFeb 18, 2025High Capture Threshold; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394226 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEM INFECTION AND EROSION. IT WAS ALSO NOTED THAT THE PATIENT DEVELOPED PAIN AND REDNESS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Pain; Unspecified Infection

  MAUDE report 21371003 ↗
• MalfunctionNov 20, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THERE WAS POSSIBLE NOISE SEEN ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD CHANNELS. IT WAS NOTED THAT ONCE THE SIGNAL BEGAN GETTING SENSED ON THE RV CHANNEL IT RESULTED IN PACING INHIBITION. THE RA LEAD AND 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 20738941 ↗
• MalfunctionNov 7, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLD AND A SINGLE T-WAVE OVERSENSING (TWOS) BEAT ON THE RIGHT VENTRICULAR (RV) LEAD. THE 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 20635314 ↗
• MalfunctionOct 7, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC ELEVATED THRESHOLDS AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDER-SENSING. THE 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 20382291 ↗
• MalfunctionOct 3, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED ATRIAL LEAD POSITION CHECK FAILURE. 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 20357982 ↗
• InjurySep 11, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN AN INAPPROPRIATE SHOCK DELIVERED FOR DETECTED VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE RHYTHM WAS POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20191350 ↗
• InjuryAug 20, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "FEELING OF CHEST MUSCLE MOVEMENT". THE IPG WAS REPROGRAMMED AND REMAINS IN USE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH RATE EPISODES AND A POSSIBLE INSULATION BREACH. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH RATE EPISODES. THE RA AND THE RV LEADS WERE REPROGRAMMED AND 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 20004140 ↗
• MalfunctionJul 10, 2024Over-Sensing; Pacing Problem; Under-Sensing; High Capture Threshold; Over-Sensing; Pacing Problem; Under-Sensing; High Capture Threshold

  IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE EXHIBITED OVERSENSING OF ATRIAL ACTIVITY AND UNDERPACING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709830 ↗
• InjuryJun 20, 2024Adverse 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 WITH NO REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19573085 ↗
• MalfunctionApr 3, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER-SENSING DURING VENTRICULAR ARRHYTHMIA. THE RV LEAD REMAINS IN U SE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19030485 ↗
• InjuryMar 25, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE. THE LEAD WAS REPROGRAMMED BEFORE BEING 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 18968449 ↗