Selectsecure™ 383059 (UDI 00643169279292)Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00643169279292), received between Dec 7, 2016 and Sep 15, 2026 — classified as 52 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Under-Sensing” (27 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 86 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Fracture; High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high and undefined impedance warnings and had fractured. The RV 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 50774398 ↗
• MalfunctionJan 20, 2026Under-Sensing

  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 24113097 ↗
• 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 24036618 ↗
• InjuryNov 11, 2025Over-Sensing; Device Dislodged or Dislocated; High Capture Threshold; Over-Sensing; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED POST POCKET CLOSURE AND EXHIBITED HIGH THRESHOLDS AND A HIGH SENSING INTEGRITY COUNTER (SIC). 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 23520216 ↗
• MalfunctionJun 9, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING NOTED ON CURRENT AND STORED ELECTROGRAMS (EGM), RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AND INAPPROPRIATE ATRIAL PACING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22165572 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS INFECTED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A BIG IMPEDANCE RISE AND HIGH THRESHOLD. 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 22139502 ↗
• InjuryJun 4, 2025High impedance; Impedance Problem; High Capture Threshold; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS INFECTED. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A BIG IMPEDANCE RISE AND HIGH THRESHOLD. 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 22139495 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22061346 ↗
• MalfunctionMay 13, 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 22008816 ↗
• InjuryMar 7, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS BOTH EXHIBITED INTERMITTENT UNDER SENSING. IT WAS NOTED THAT THE PATIENT EXPERIENCED PALPITATIONS. BOTH LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 21546094 ↗
• MalfunctionJan 23, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT RESULTED IN 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 21218873 ↗
• MalfunctionJan 16, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE UNDERSENSING, RESULTING IN INAPPROPRIATE ATRIAL PACING AND FALSE TERMINATION OF ATRIAL EVENTS. 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 21172978 ↗
• MalfunctionNov 27, 2024Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE ATRIAL PACING. THE RA LEAD WAS 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 20797802 ↗
• InjuryNov 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DISLODGEMENT POST POCKET CLOSURE. THE RV LEAD WAS EXPLANTED AND REPLA CED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778538 ↗
• MalfunctionNov 20, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD ON A STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE. 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 20735371 ↗
• MalfunctionNov 15, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE UNDERSENSING DURING A VENTRICULAR ARRHYTHMIA EVENT. 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 20696221 ↗
• MalfunctionOct 8, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LOSS OF CAPTURE. 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 20396393 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A POSSIBLE FRACTURE. IN ADDITION, IT WAS NOTED THAT THE ATRIUM WAS PERFORATED, THEREFORE THE SURGEON ELECTED TO REMOVE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD, AS THE SAME TIME AS THE RV LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation

  MAUDE report 20274791 ↗
• InjurySep 18, 2024High 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 CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20246469 ↗
• InjuryJul 3, 2024Signal Artifact/Noise; Over-Sensing; Under-Sensing; Signal Artifact/Noise; Over-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE RA LEAD WAS REPROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666572 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. VEGETATION/GROWTH WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19019500 ↗
• InjuryMar 4, 2024Failure to Capture; Pacing Problem; Capturing Problem; Failure to Capture; Pacing Problem; Capturing Problem

  IT WAS REPORTED THAT DURING THE IMPLANTABLE PULSE GENERATOR (IPG) CHANGE OUT PROCEDURE, LOSS OF CAPTURE WAS NOTED WHEN ON BOVIE AND DELAY IN CAPTURE FOR A FEW BEATS WAS NOTED AFTER BOVIE STOPPED. PACING WAS OBSERVED TO BE RESUMED WHEN PRESSURE WAS APPLIED ON THE DEVICE POCKET. THE RIGHT VENTRICULAR (RV) HIS BUNDLE LEAD WAS CAPPED AND REPLACED. THE IPG 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 18824648 ↗
• 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 18524884 ↗
• InjuryDec 15, 2023Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED TRENDS OF FALLING IMPEDANCE AND NOISE WAS ALSO OBSERVED. 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 18333935 ↗
• MalfunctionNov 14, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT DURING USE OF THE RIGHT ATRIAL (RA) LEAD, UNDERSENSING NOTED ON STORED AND CURRENT ELECTROGRAMS (EGM), NO IMPACT OBSERVED. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) , THERAPY POTENTIALLY INAPPROPRIATELY WITHHELD BY SUPRA VENTRICULAR TACHYCARDIA (SVT) ONSET DISCRIMINATOR FOR DURING A VENTRICULAR TACHYCARDIA (VT) EPISODE.  THE CRT-D 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 18134137 ↗