Sprint Quattro Secure S™ 693565Recalls & reported problems

Summary

The FDA's MAUDE database contains 657 adverse event reports that list this exact device (DI 00613994446350), received between Aug 7, 2014 and Sep 30, 2026 — classified as 10 deaths, 420 injuries, 227 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (267 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 657 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia

  MAUDE report 50951342 ↗
• InjurySep 25, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903852 ↗
• InjurySep 15, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited non-physiologic oversensing. 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 50777295 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced a systemic infection with fever. The patient was hospitalized and the device system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50531164 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection that presented with purulent discharge/pus and redness. The Implantable Cardioverter Defibrillator (ICD) was explanted. The Right Atrial (RA) lead and Right Ventricular (RV) lead were capped and remain in the patient. No further patient complications have been reported as a result of this event.

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 50376516 ↗
• InjuryAug 13, 2026Over-Sensing; Pacing Problem; Defibrillation/Stimulation Problem; Under-Sensing

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) may have inappropriately classified Ventricular Tachycardia (VT) episodes as Supra Ventricular Tachycardia (SVT) and delayed therapy due to stability and onset discriminators. It was also reported that there was Right Ventricular (RV) lead oversensing and undersensing observed which may have resulted in over pacing and delayed episode detection at times. A Lead Integrity Alert (LIA) triggered for the RV lead due to High Rate Non-Sustained episodes and elevated Sensing Integrity Counter (SIC). The CRT-D and RV lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50237828 ↗
• MalfunctionAug 7, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50176058 ↗
• InjuryJul 30, 2026High impedance

  It was reported that the Right Atrial (RA) lead exhibited Out of Range (OOR) low pacing impedance and the Right Ventricular (RV) lead exhibited OOR high pacing impedance. The lead were capped. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091687 ↗
• MalfunctionJul 9, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25766129 ↗
• MalfunctionJul 2, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE 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 25692333 ↗
• MalfunctionJun 16, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DUE TO LOW P-WAVES CAUSING NO ATRIAL MARKERS ON THE ELECTROGRAMS (EGM). IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RA AND RV 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 25522252 ↗
• InjuryJun 16, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Impedance Problem; High Capture Threshold; Unstable Impedance

  IT WAS REPORTED THAT DURING USE THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED LEAD INTEGRITY ALERT (LIA) FOR TWO OR MORE HIGH RATE-NS EP ISODES, SENSING INTEGRITY COUNTER (SIC), RV PACING IMPEDANCE VARIATION. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCE, A SPIKE IN RV PACING IMPEDANCE, ALERT TRIGGERED FOR OVERSENSING NOISE AND THE LEAD EXHIBITED HIGH THRESHOLDS. ADDITIONALLY, THE RV LEAD EXHIBITED OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. ALL HIGH VOLTAGE THERAPIES WERE PROGRAMMED OFF AND SUBSEQUENTLY 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 25521367 ↗
• MalfunctionJun 15, 2026Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN IMPEDANCE WARNING FOR UNDEFINED HIGH PACING IMPEDANCES AND UNDEFINED HIGH RV DEFIBRILLATION IMPEDANCES. IN ADDITION, THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN IMPEDANCE WARNING FOR UNDEFINED HIGH PACING IMPEDANCES. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. NOISE WAS ALSO NOTED ON THE RV, LV AND RA LEADS TRIGGERING EPISODE MISCLASSIFICATION. THE RV, LV AND RA 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 25504836 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 25483928 ↗
• InjuryJun 2, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR UNDEFINED HIGH RV PACING IMPEDANCE. TWO LEAD INTEGRITY ALERTS (LIA) OCCURRED OVER A TWO-MONTH PERIOD: ONE DUE TO AN ELEVATED SENSING INTEGRITY COUNTER (SIC) VALUE AND HIGH RATE NON-SUSTAINED EPISODES, AND ANOTHER DUE TO AN ELEVATED SIC VALUE AND VARIATION IN RV PACING LEAD IMPEDANCE. AN ADDITIONAL ALERT FOR OVERSENSING OF NOISE WAS ALSO REPORTED. THERAPIES WERE PROGRAMMED OFF DUE TO A SUSPECTED LEAD INTEGRITY ISSUE. THE LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25361718 ↗
• InjuryMay 20, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDEFINED HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231755 ↗
• MalfunctionMay 8, 2026High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE HOSPITAL WITH COMPLAINTS OF DIZZINESS/NEAR SYNCOPE AND NAUSEA. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON STORED EPISODES, HIGH THRESHOLDS, AND HIGH, OUT-OF-RANGE, UNDEFINED PACING IMPEDANCES. THE THRESHOLD AND PACING IMPEDANCE VALUES WERE KNOWN AND THE PACING IMPEDANCE VALUES WERE CONSISTENT WITH HISTORICAL MEASUREMENTS. IT WAS ALSO REPORTED THAT THE RV LEAD HAD TRIGGERED A HISTORICAL LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND THE SENSING INTEGRITY COUNTER (SIC) BEING INCREMENTED. THERE WAS ALSO A HISTORICAL RV LEAD IMPEDANCE ALERT DUE TO HIGH, OUT-OF-RANGE, UNDEFINED PACING IMPEDANCES. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Nausea; Presyncope

  MAUDE report 25124933 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. IT WAS NOTED THAT VEGETATION WAS ON THE RIGHT VENTRICULAR (RV) LEAD DISTAL TO THE TRICUSPID VALVE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25047526 ↗
• InjuryApr 10, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND THE SENSING INTEGRITY COUNTER (SIC) BEING INCREMENTED. THE RV LEAD ALSO EXHIBITED OVERSENSING IN NON-PHYSIOLOGIC INTERVALS IN STORED EPISODES. 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 24845161 ↗
• MalfunctionApr 2, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED A RING FRACTURE. 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 24767594 ↗
• MalfunctionMar 11, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND THE SENSING INTEGRITY COUNTER (SIC) HAD BEEN INCREMENTED. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED OVERSENSING ON A STORED EPISODE, RESULTING IN MISCLASSIFICATION OF EPISODE TYPE AND NOISE. IT WAS FURTHER REPORTED THAT THE RV LEAD TRIGGERED AN ALERT DUE TO HIGH, OUT-OF-RANGE, UNDEFINED RV DEFIBRILLATION 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 24574577 ↗
• MalfunctionMar 11, 2026Over-Sensing; Under-Sensing; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING, OVERSENSING, AND T-WAVE OVERSENSING (TWOS). THE LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT V-V SENSING INTEGRITY COUNTER (SIC). ADDITIONALLY, THE LEAD HAD INCREASING AND HIGH CAPTURE THRESHOLD. 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 24569582 ↗
• MalfunctionMar 2, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 24485237 ↗
• InjuryFeb 23, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR HIGH UNDEFINED DEFIBRILLATION IMPEDANCE MEASUREMENTS. THE LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24416115 ↗
• InjuryFeb 11, 2026High impedance; Connection Problem; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LAB WHERE IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) L EAD PIN WAS NOT PAST THE SET SCREW IN THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEAD WAS REINSERTED INTO THE DEVICE. THE LEAD AND DEVICE REMAIN IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316637 ↗