Sprint Quattro Secure S™ 693558Recalls & reported problems

Summary

The FDA's MAUDE database contains 515 adverse event reports that list this exact device (DI 00613994446343), received between Aug 10, 2013 and Aug 28, 2026 — classified as 4 deaths, 340 injuries, 171 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (209 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 515 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Fracture; Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited oversensing and was suspected to have a low voltage fracture. The pat ient experienced dizziness. The RV lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: Dizziness

  MAUDE report 50508322 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced staphylococcus aureus infection with staph in the blood, bacteremia and fever.  The device system remains in use, No further patient complications have been reported as a result of this event. It was further reported that the ICD system was explanted.

  Patient problems: Bacteremia; Bacterial Infection; Fever

  MAUDE report 50327489 ↗
• InjuryJul 29, 2026Fracture

  It was reported that the Right Ventricular (RV) lead had a confirmed fracture. A previous RV lead that was abandoned in the right ventricle was also confirmed to have a fracture. Both leads 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 50074797 ↗
• MalfunctionJul 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). 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 25736998 ↗
• MalfunctionMay 18, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND CAUSING INAPPROPRIATE ATRIAL PACING. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE. 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 25203568 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 25143707 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. A NEW ICD SYSTEM WAS IMPLANTED APPROXIMATELY A WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25019269 ↗
• MalfunctionApr 27, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING THRESHOLDS AND TRIGGERED AN ALERT DUE TO 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 25008354 ↗
• MalfunctionApr 6, 2026Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) LOW RV TIP TO RV COIL PACING IMPEDANCE AND 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 24794314 ↗
• MalfunctionMar 30, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED DEFIBRILLATION IMPEDANCE. 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 24730661 ↗
• InjuryMar 16, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Capturing Problem; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT THE LOW VOLTAGE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. NON-PHYSIOLOGICAL OVERSENSING AND OVERSENSING OF NOISE AND RISING THRESHOLDS WAS OBSERVED. AN ALERT WAS TRIGGERED DUE TO HIGH OUT OF RANGE (OOR) PACING IMPEDANCE AND A SPIKE IN PACING IMPEDANCE MEASUREMENTS WAS NOTED. VARIABILITY IN PACING IMPEDANCE MEASUREMENTS WAS ALSO NOTED. REPROGRAMMING OCCURRED. 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 24613421 ↗
• MalfunctionMar 4, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN FALSE TERMINATION OF VENTRICULAR ARRHYTHMIA. 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 24507178 ↗
• MalfunctionMar 3, 2026Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). THE RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED OVERSENSING RESULTING IN T-WAVE OVERSENSING (TWOS). THE DEVICE AND LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED VIA FOLLOW-UP WITH THE CLINIC THAT THE PATIENT HAD BEEN HOSPITALIZED AND THEIR MEDICATIONS WERE ADJUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497265 ↗
• MalfunctionMar 3, 2026Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN CAPTURE THRESHOLD MEASUREMENTS. 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 24494758 ↗
• InjuryFeb 24, 2026Fracture; Over-Sensing; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND PACING IMPEDANCE VARIATION. ADDITIONALLY, THE LEAD DISPLAYED OVERSENSING AND A JUMP IN PACING IMPEDANCE. 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 24436412 ↗
• InjuryFeb 9, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED TO BE FRACTURED. SUBSEQUENTLY, THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK. ADDITIONALLY, THE LEAD TRIGGERED ALERTS FOR NOISE AND UNDEFINED HIGH PACING IMPEDANCE. THE LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24300408 ↗
• MalfunctionFeb 9, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING WHICH RESULTED IN INAPPROPRIATE PACING. ATRIAL CAPTURE WAS UNABLE TO BE CONFIRMED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD POSSIBLY EXHIBITED OVERSENSING. POSSIBLE OVERSENSING ON THE VENTRICULAR LEAD DURING NON-PHYSIOLOGIC INTERVALS WAS OBSERVED. 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 24290401 ↗
• MalfunctionFeb 4, 2026Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN RV TIP TO RV COIL IMPEDANCE WARNING. 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 24259800 ↗
• InjuryJan 30, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO A FRACTURE ON THE LOW VOLTAGE PORTION OF THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24227899 ↗
• InjuryJan 14, 2026Fracture; Over-Sensing; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071900 ↗
• MalfunctionJan 12, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH-RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE LEAD ALSO EXHIBITED OVERSENSING IN NON-PHYSIOLOGIC INTERVALS. IT WAS STATED THAT THE PATIENT HAD A PROCEDURE ON THE SAME DAY AS THE STORED ELECTROGRAMS (EGM)S WITH THE OVERSENSING. 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 24045861 ↗
• MalfunctionJan 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AND INAPPROPRIATE ATRIAL PACING AT TIMES. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THE RA AND RV LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OFTHIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23978789 ↗
• InjuryJan 2, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED PACING IMPEDANCE INDICATING AN RV RING FRACTURE. THE PATIENT WAS ADMITTED AND THE LEAD WAS REPROGRAMMED. 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 23950416 ↗
• MalfunctionDec 29, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR PACING. 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 23915494 ↗
• InjuryDec 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURE. IT WAS NOTED THAT VENTRICULAR FIBRILLATION (VF) DETECTION/THERAPIES WERE PROGRAMMED OFF. 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 23759039 ↗