SELECTSECURE™ 383069 (UDI 00643169535879)Recalls & reported problems

Summary

The FDA's MAUDE database contains 318 adverse event reports that list this exact device (DI 00643169535879), received between Dec 9, 2016 and Jul 14, 2026 — classified as 1 death, 225 injuries, 92 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (155 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 318 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25812143 ↗
• InjuryJul 3, 2026Intermittent Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS AND INTERMITTENT CAPTURE. IT WAS NOTED THAT THE HIS BUNDLE LEAD WAS REPOSITIONED TO THE LEFT VENTRICULAR (LV) PORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702171 ↗
• MalfunctionJun 24, 2026Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND UNDER SENSING. 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 25608817 ↗
• InjuryMay 21, 2026Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLDS. 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 25241825 ↗
• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES, RESULTING IN TERMINATION OF AT/AF DETECTIONS IN PROGRESS. THE RA LEAD ALSO EXHIBITED HIGH PACING THRESHOLDS. THE LEFT VENTRICULAR (LV) LEAD WAS REPORTED TO HAVE A RING ELECTRODE FRACTURE. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS OR ADVERSE CLINICAL OUTCOMES HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25021270 ↗
• MalfunctionApr 22, 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 24950204 ↗
• MalfunctionApr 7, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF ATRIAL LEAD ACTIVITY ON THE ELECTROGRAMS (EGM) RESULTING IN INHIBITED PACING. 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 24799810 ↗
• InjuryApr 3, 2026Failure to Capture; Capturing Problem

  IT WAS REPORTED THAT THE HIS BUNDLE LEAD EXHIBITED INCREASED THRESHOLDS WITH PRESUMED INTERMITTENT LOSS OF CAPTURE. THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778302 ↗
• InjuryMar 26, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. 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 24700395 ↗
• InjuryMar 13, 2026Intermittent Capture; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588813 ↗
• InjuryFeb 13, 2026Failure to Capture; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIGHTHEADEDNESS AND THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED LOSS OF CAPTURE AND HIGH AND VARIABLE THRESHOLDS. THE RV HIS BUNDLE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 24331571 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT THAT THEY PREVIOUSLY HAD A DISLODGED LEAD AND DESCRIBED FEELING IT AND NOTED THAT "IT HURT." THE HIS BUNDLE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24225605 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A FALL WITH MALAISE AND IMPLANTABLE PULSE GENERATOR (IPG) SITE SWELLING, FEVER, CONFUSION, HYPERTENSION AND FLUID IN THE IPG POCKET INFECTION. THE PATIENT FURTHER EXPERIENCED SEPSIS DUE TO METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS ENDOCARDITIS. THE PATIENT WAS TRANSFERRED TO INTENSIVE CARE UNIT (ICU) AND MEDICATION WAS ADMINISTERED. THE IPG SYSTEM WAS EXPLANTED AND FLUID WAS DRAINED. THE PATIENT WAS TRANSIENTLY HYPOTENSIVE AND A TRANSESOPHAGEAL ECHOCARDIOGRAM REVEALED MITRAL VALVE VEGETATION. THE PATIENT ALSO HAD TRACE LEFT LOWER EXTREMITY EDEMA. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24019724 ↗
• InjuryAug 25, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED AND REMAINS IN USE.

  Patient problems: Arrhythmia

  MAUDE report 22882664 ↗
• InjuryJun 17, 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), THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 22229314 ↗
• InjuryJun 5, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT SINCE SHORTLY AFTER IMPLANT, THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED DIMINISHED SENSING. THE IMPLANTABLE PULSE GENERATOR (IPG) ALSO EXHIBITED POSSIBLE FALSE ELECTIVE REPLACEMENT INDICATOR (ERI). THE IPG SYSTEM WAS REPROGRAMMED AND THEN EXPLANTED AND REPLACED. THE RV LEAD PARTIALLY BROKE OFF DURING TIGHT-RAIL EXTRACTION AND THE REMAINDER WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148673 ↗
• InjuryMay 15, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD NO CAPTURE. THE LEAD WAS REPROGRAMMED AND 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 22029354 ↗
• InjuryApr 30, 2025Under-Sensing; High Capture Threshold; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 21932630 ↗
• MalfunctionNov 12, 2024Failure to Capture; Pacing Problem; Under-Sensing; Device Sensing Problem; High Capture Threshold; Failure to Capture; Pacing Problem; Under-Sensing; Device Sensing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED UNDERSENSING ON CURRENT ELECTROGRAMS (EGM). 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 20662672 ↗
• InjuryAug 26, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE IPG AND RV LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063724 ↗
• MalfunctionJul 15, 2024Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD VARIABLE CAPTURE. A VENOGRAM CONFIRMED THAT THE VEIN WAS OCCLUDED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19738634 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD WAS EXPLANTED PROPHYLACTICALLY, RETURNED, ANALYZED AND TESTED OUT OF SPECIFICATION FOR AN INSULATION BREACH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19284592 ↗
• InjuryApr 16, 2024High Capture Threshold; High Capture Threshold

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116457 ↗
• MalfunctionMar 29, 2024Failure to Capture; Over-Sensing; Failure to Capture; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT FIRING OR WORKING PROPERLY. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND A HIGH NUMBER OF SENSING INTEGRITY COUNTER (SIC). THE IPG 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 19006573 ↗
• MalfunctionMar 28, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO NOTED THAT THE HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS AND LOSS OF CAPTURE. IT WAS FURTHER NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON ATRIAL LEAD NOTED ON STORED ELECTROGRAMS(EGM), RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTION. THE HIS BUNDLE AND RA LEADS 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 18999827 ↗