Sprint Quattro Secure S™ DXAC/DSP 693558 (UDI 00613994446091)Recalls & reported problems

Summary

The FDA's MAUDE database contains 607 adverse event reports that list this exact device (DI 00613994446091), received between Oct 9, 2013 and Sep 29, 2026 — classified as 3 deaths, 380 injuries, 224 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (255 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 607 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937723 ↗
• MalfunctionSep 9, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696614 ↗
• MalfunctionAug 14, 2026Fracture; High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263000 ↗
• InjuryAug 11, 2026High impedance

  It was reported that high out-of-range impedance was observed on the defibrillation coil of the implanted right ventricular (RV) lead. The patient underwent surgical replacement of the RV lead which was capped. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50210184 ↗
• MalfunctionJul 27, 2026Low impedance; Unstable Impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50009562 ↗
• MalfunctionJun 19, 2026Impedance Problem

  IT WAS REPORTED THAT THERE WAS WARNING FOR RIGHT VENTRICULAR (RV) LEAD 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 25563790 ↗
• MalfunctionJun 11, 2026High impedance; Mechanical Problem

  IT WAS REPORTED THAT SHORTLY AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH UNDEFINED RV DEFIBRILLATION IMPEDANCES. A CONNECTION ISSUE WAS SUSPECTED. THE ICD 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 25474736 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS RELATED TO AN INFECTION. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25384771 ↗
• InjuryMay 22, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING DURING AN EVENT. THE PATIENT RECEIVED ANTI-TACHYCARDIA P ACING (ATP) AND A SHOCK. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25262635 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT EXPERIENCED AN INFECTION WITH VEGETATION NOTED IN THE RIGHT ATRIUM AND TRICUSPID VALVE. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND THE REMAINDER OF THE SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25219023 ↗
• MalfunctionMay 11, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. 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 25144044 ↗
• MalfunctionApr 24, 2026High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH-RATE NON-SUSTAINED EPISODES AND HIGH SENSING INTEGRITY COUNTER (SIC). IT WAS NOTED THAT THE RV LEAD HAD A BIPOLAR LEAD IMPEDANCE WARNING DUE TO HIGH AND UNDEFINED IMPEDANCE MEASUREMENTS. 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 24986181 ↗
• InjuryApr 21, 2026Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO RIGHT VENTRICULAR (RV) LEAD OVERSENSING. THE RV LEAD EXHIBITED HIGH OUT OF RANGE THRESHOLDS AND PACING IMPEDANCE, AND ELEVATED SENSING INTEGRITY COUNTER (SIC), THE RV LEAD WAS SUSPECTED TO BE FRACTURED. THE RIGHT ATRIAL (RA) LEAD EXHIBITED RISING IMPEDANCE, RISING AND HIGH THRESHOLDS. THE RV AND RA LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941700 ↗
• MalfunctionApr 17, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW 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 24916025 ↗
• MalfunctionApr 14, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR UNDEFINED HIGH 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 24877180 ↗
• MalfunctionMar 31, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING ON A STORED EPISODE, RESULTING IN T-WAVE OVERSENSING (TWOS) AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED EPISODES. 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 24746885 ↗
• MalfunctionMar 4, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED OVERSENSING AND UNDERSENSING ON STORED ELECTROGRAMS (EGMS). 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 24513987 ↗
• InjuryFeb 26, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD NOISE WARNING AND AN LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE RV LEAD ALSO EXHIBITED OVERSENSING/NOISE. THE RA LEAD TRIGGERED A HIGH OUT OF RANGE IMPEDANCE ALERT. THE RA AND RV 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 24458342 ↗
• InjuryFeb 25, 2026Fracture; High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443631 ↗
• InjuryFeb 17, 2026Defibrillation/Stimulation Problem; Positioning Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE IN THE HOSPITAL BECAUSE OF A FAINTING SPELL AND "PASSED OUT" THE DAY PRIOR. THE PATIENT STATED THAT "THEY SHOWED A TACHYCARDIA OR SOMETHING IN MY HEART THING". ADDITIONALLY, THE PATIENT MENTIONED THE PHYSICIAN THAT IMPLANTED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SAID ONE OF THE LEADS WAS NOT PLACED RIGHT IN THEIR "FIRST ONE" AND WHEN THE PATIENT FAINTED, THE DEFIBRILLATION "DID NOT GO OFF". THE PATIENT ALSO STATED THE LEFT VENTRICULAR (LV) LEAD WAS NOT PLACED PROPERLY SO INSTEAD OF GOING IN TO RECONNECT THE LEAD, "IT WAS HARD FOR THEM TO SYNC BETWEEN THE RIGHT VENTRICULAR (RV) LEAD AND THE LV LEAD". IN ADDITION, THE PATIENT SAID THAT WHEN THEY WERE IN THE HOSPITAL, THE STAFF TOLD THEM THAT THE REASON THEY FAINTED WAS BECAUSE OF ATRIAL FIBRILLATION (AF) AND THAT THEIR DEVICE SHOULD HAVE GONE OFF. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Syncope/Fainting; Tachycardia

  MAUDE report 24368698 ↗
• MalfunctionFeb 12, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FEELING UNWELL. A DEVICE INTERROGATION INDICATED A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. ISOLATED T-WAVE OVERSENSING (TWOS) WAS ALSO OBSERVED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Malaise

  MAUDE report 24322687 ↗
• InjuryFeb 6, 2026Signal Artifact/Noise; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED DUE TO VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD EXHIBITED INTERMITTENT NOISE, NON-PHYSIOLOGIC/SENSING INTEGRITY COUNTERS (SIC) AND A SUSPECTED LEAD FRACTURE. THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK AND THERAPIES WERE TURNED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Shock from Patient Lead(s)

  MAUDE report 24280930 ↗
• MalfunctionFeb 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING POSSIBLY WHEN THE PATIENT WAS RECEIVING CARDIOPULMONARY RESUSCITATION AT THE TIME. 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 24279052 ↗
• MalfunctionFeb 3, 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 24247324 ↗
• MalfunctionJan 28, 2026Fracture; High impedance; Over-Sensing; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH-RATE NON-SUSTAINED EPISODES. IN ADDITION, THE RV LEAD TRIGGERED ALERTS FOR UNDEFINED HIGH RV DEFIBRILLATION COIL IMPEDANCES AND UNDEFINED HIGH RV PACING IMPEDANCES. IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED OVERSENSING RESULTING IN FALSE EPISODE DETECTIONS. IT WAS ALSO REPORTED THAT SHOCKS WERE DELIVERED WITH OUTPUT LESS THAN THE PROGRAMMED OUTPUT. AFTER FURTHER REVIEW, IT WAS DETERMINED THAT AN RV LEAD FRACTURE OR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONNECTION ISSUE WAS MOST LIKELY IMPACTING THE THERAPY DELIVERY. THE ICD AND 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 24201985 ↗