SELECTSECURE™ 383059 (UDI 00643169535886)Recalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 00643169535886), received between Jan 4, 2017 and Jun 2, 2026 — classified as 2 deaths, 46 injuries, 23 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (18 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 71 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Signal Artifact/Noise; Break; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND NOISE. IT WAS NOTED THAT THE SUPERIOR VENA CAVA (SVC) STENT COULD HAVE CAUSED DAMAGE TO THE RA LEAD. THE RA 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 25358255 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 24995502 ↗
• 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 24019685 ↗
• MalfunctionMay 14, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE OVERSENSING. 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 22018512 ↗
• InjuryMar 31, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT HIGH RIGHT VENTRICULAR (RV) THRESHOLDS WERE OBSERVED ON THE RV LEAD. IT WAS NOTED THAT THE HIGH RV THRESHOLDS LED TO FAST BATTERY DEPLETION OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE RV LEAD AND IPG 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 21729712 ↗
• MalfunctionJan 16, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) 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 21172504 ↗
• InjuryJan 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS INACTIVATED AND REPLACED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137249 ↗
• MalfunctionOct 1, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS POTENTIAL RIGHT ATRIAL (RA) LEAD UNDERSENSING THAT WAS TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AT TIMES. 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 20347918 ↗
• MalfunctionApr 25, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOSS OF CAPTURE ON STORED ELECTROGRAMS (EGM), AND THAT THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) 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 19182859 ↗
• InjuryJan 2, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) BACHMANNS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS. THE RA 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 18424287 ↗
• InjuryDec 20, 2023Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  ADDITIONAL INFORMATION FROM THE PHYSICIAN OFFICE NOTED THAT THERE WAS AN INCREASE IN LEFT VENTRICULAR (LV) LEAD IMPEDANCE MEASUREMENT AND AN ELECTRODE FRACTURE. PROGRAMMING CHANGES WERE PERFORMED TO ADDRESS THE LV LEAD AND THE INTERMITTENT UNDERSENSING SECONDARY TO ATRIAL FLUTTER OF THE RA LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367097 ↗
• MalfunctionNov 9, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT RECEIVE MULTIPLE INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT)/SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS NOTED THAT THE CRT-D TRIGGERED A FALSE OBSERVATION FOR AN INCREASE IN THE LV LEAD THRESHOLD INDICATING THAT THE INCREASE WAS GREATER THAN THE AMPLITUDE SAFETY MARGIN AND MAY HAVE COMPROMISED CAPTURE. THE OBSERVATION DISPLAYED QUESTION MARKS WHERE A NUMERICAL VALUE WOULD TYPICALLY BE DISPLAYED. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR AN OUT OF RANGE (OOR) IMPEDANCE. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD EXHIBITED SUSPECTED INTERMITTENT UNDERSENSING DURING RECORDED EPISODES. LASTLY, THE HIS BUNDLE LEAD EXHIBITED LOW IMPEDANCE. THE CRT-D, RV LEAD, RA LEAD, AND HIS BUNDLE 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 18104130 ↗
• MalfunctionSep 26, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 17816682 ↗
• DeathJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY WITH THE CAUSE OF DEATH BEING DUE TO MIXED SEPTIC AND CARDIOGENIC SHOCK THEN ACUTE RENAL AND HYPOXIC RESPIRATORY FAILURE.

  Patient problems: Cardiogenic Shock; Renal Failure; Respiratory Failure; Septic Shock; Unspecified Infection

  MAUDE report 17345826 ↗
• MalfunctionMay 23, 2023High Capture Threshold; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE PATIENT'S SYMPTOMS WERE NOT THOUGHT TO BE RELATED TO THE RA LEAD.

  Patient problems: Dyspnea

  MAUDE report 16982480 ↗
• InjuryMay 17, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING ON CURRENT ELECTROGRAMS (EGM). 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 16945777 ↗
• InjuryNov 30, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO CAPTURE. DURING RA LEAD REVISION PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO BE ENTANGLED TO THE RA LEAD IN THE VEIN WHICH REQUIRED BOTH LEADS TO BE EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884575 ↗
• MalfunctionNov 11, 2022Failure to Capture; Decreased Sensitivity; High Capture Threshold; Unstable Capture Threshold; Failure to Capture; Decreased Sensitivity; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EPISODE OF SUPRA VENTRICULAR TACHYCARDIA (SVT) AND ATRIAL ARRHYTHMIA. IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) - HIS BUNDLE LEAD EXHIBITED HIGH THRESHOLDS AND CHRONICALLY LOW R WAVES WERE NOTED. IT WAS REPORTED THAT THE RV-HIS LEAD EXHIBITED VARYING RV CAPTURE THRESHOLD OVER TIME, AND RV CAPTURE WAS UNABLE TO BE ASSESSED ON THE CURRENT ELECTROGRAM. THE RV - HIS BUNDLE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Tachycardia

  MAUDE report 15778212 ↗
• MalfunctionAug 19, 2022Under-Sensing; Under-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 HAD LOW R WAVES THAT HAD BEEN TRENDING DOWN. 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 15258615 ↗
• InjuryAug 18, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND NEAR SYNCOPE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Presyncope

  MAUDE report 15250274 ↗
• InjuryJul 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD DISLODGED. 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 14945150 ↗
• InjuryMay 9, 2022Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND THAT RV PACING CAPTURE THRESHOLDS HAD BEEN STEADILY RISING FOR THE LAST TWELVE MONTHS. PATIENT IS PACEMAKER DEPENDENT SO THE RV LEAD WAS EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14337572 ↗
• MalfunctionMar 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HIGH IMPEDANCE AND POLARITY SWITCH. THE LEAD WAS EXPLANTED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  MAUDE report 13769386 ↗
• InjuryMar 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS EXHIBITED HIGH IMPEDANCE WARNINGS. BOTH LEADS WERE EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732888 ↗
• MalfunctionJan 31, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POKING FEELING ON THEIR LEFT SIDE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13391429 ↗