Sprint Quattro Secure S™ DXAC/DSP 693565 (UDI 00613994446107)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,012 adverse event reports that list this exact device (DI 00613994446107), received between Oct 10, 2013 and Sep 29, 2026 — classified as 11 deaths, 620 injuries, 381 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (411 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 1,012 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026High impedance; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935771 ↗
• MalfunctionSep 28, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922020 ↗
• MalfunctionSep 16, 2026Unstable Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794176 ↗
• MalfunctionSep 15, 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 Sensing Integrity Counter (SIC) while the patient was resting in bed watching television. 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 50773873 ↗
• MalfunctionSep 10, 2026High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high/undefined pacing 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 50715809 ↗
• MalfunctionSep 8, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675045 ↗
• InjuryAug 27, 2026Device Dislodged or Dislocated

  It was reported by the patient that the physician had to go back and put a longer wire in because "it came off". No additional information could be obtained through follow-up with the clinic. The Right Ventricular (RV) lead was inactivated and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484103 ↗
• MalfunctionAug 27, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited 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 50470111 ↗
• MalfunctionAug 17, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) post-ventricular sensing. 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 50276457 ↗
• MalfunctionAug 4, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50134270 ↗
• InjuryJul 29, 2026Intermittent Capture; Fracture; Inappropriate/Inadequate Shock/Stimulation; Unstable Capture Threshold

  It was reported that the patient received an inappropriate shock due to a suspected high voltage Right Ventricular (RV) lead fracture. In addition, the RV lead exhibited unstable thresholds and intermittent capture. The patient also experienced dizziness. The RV lead was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Dizziness; Shock from Patient Lead(s)

  MAUDE report 50077589 ↗
• MalfunctionJun 11, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EXHIBITED 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 25471583 ↗
• MalfunctionJun 8, 2026Signal Artifact/Noise; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IS FRACTURED. NOISE WAS OBSERVED AND 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 25437986 ↗
• MalfunctionJun 2, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) RESULTING IN LOSS OF 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 25361172 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO POCKET INFECTION WITH DRAINAGE. IT WAS NOTED THAT THERE WAS POSSIBLE VEGETATION. THE PATIENT EXPERIENCED DISCOMFORT, FEVER, SWELLING, AND WOUND DEHISCENCE. AT THE TIME OF THE EXPLANT PROCEDURE, THE PHYSICIAN OBSERVED RIGHT VENTRICULAR (RV) LEAD PERFORATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Fever; Fluid Discharge; Medical device site infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25356066 ↗
• MalfunctionMay 27, 2026Low impedance; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR LOW OUT OF RANGE PACING IMPEDANCES. IN ADDITION, THE RV LEAD EXHIBITED LOW RV DEFIBRILLATION COIL IMPEDANCES. THE LOW PACING IMPEDANCES HAD BEEN INTERMITTENTLY LOW SINCE THE LAST DEVICE CHANGEOUT. 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 25302642 ↗
• MalfunctionMay 21, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND AN INCREASE IN PACING IMPEDANCE TO A HIGH OUT OF RANGE (OOR) VALUE. THE RV LEAD ALSO EXHIBITED POSSIBLE NOISE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED A DIAGNOSTIC ELECTRICAL RESET WHERE PARAMETER VALUES ARE UNCHANGED, RATE HISTOGRAM AND PERCENTAGE PACING DATA HAS BEEN CLEARED.. THE RV LEAD AND CRT-D 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 25247257 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE PRESUMED TO BE TAKEN OUT OF SERVICE AS WELL; HOWEVER, THE STATUS OF THE LEADS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25224534 ↗
• InjuryMay 12, 2026Failure to Capture

  IT WAS FURTHER REPORTED THAT THERE WAS REPROGRAMMING.

  Patient problems: Palpitations

  MAUDE report 25152756 ↗
• MalfunctionMay 6, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND UNDERSENSING RESULTING IN POSSIBLE MISCLASSIFICATION OF EPISODE TYPE AND MAY HAVE LED TO ADDITIONAL THERAPIES DELIVERED. THE RV LEAD ALSO EXHIBITED T-WAVE OVERSENSING (TWOS), THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF). THE LEAD AND DEVICE REMAINS IN USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107389 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS TAKEN OUT OF SERVICE. TWO MONTHS LATER A NEW ICD SYSTEM WAS IMPLANTED. THE LEAD STATUS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: Unspecified Infection

  MAUDE report 25096195 ↗
• InjuryMay 6, 2026Fracture; High impedance; Over-Sensing; Unstable Impedance

  IT WAS FURTHER REPORTED THERE WAS HIGH PACING IMPEDANCE AND A SUSPECTED LOW VOLTAGE FRACTURE ON THE RV LEAD. THE LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096119 ↗
• MalfunctionApr 29, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSE. 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 25032925 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEVER, INFECTION, AND SEPSIS POSSIBLY DUE TO A URINARY TRACT INFECTION APPROXIMATELY FOUR MONTHS PRIOR TO THE EVENT. THE PATIENT EXPERIENCED AN ADDITIONAL URINARY TRACT INFECTION APPROXIMATELY THREE MONTHS PRIOR TO THE EVENT. ADDITIONALLY, VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. DURING THE EXPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE PATIENT SUSTAINED AN INJURY TO THE RIGHT VENTRICLE REQUIRING A STERNOTOMY AND REPAIR. DURING THE EXPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE PATIENT SUSTAINED AN INJURY TO THE CORONARY SINUS THAT WAS REPAIRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Fever; Sepsis; Unspecified Infection

  MAUDE report 24974752 ↗
• MalfunctionApr 23, 2026Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND A REMOTE MONITORING TRANSMISSION INDICATED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE RA LEAD SUBSEQUENTLY EXHIBITED HIGH THRESHOLDS, A JUMPING AND FLUCTUATING IMPEDANCE, HIGH AND VARYING IMPEDANCE AND NO CAPTURE. IT WAS ALSO REPORTED THAT THERE WAS A POSSIBLE CAPTURE AND SENSING ISSUE ON THE RA LEAD AND RIGHT VENTRICULAR (RV) LEAD AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING AT A LOWER RATE OF APPROXIMATELY FIFTY-FIVE BEATS PER MINUTE WHICH IS BELOW THE PROGRAMMED LOWER RATE SETTING. THE RA LEAD, RV LEAD, AND IPG 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 24971704 ↗