Sprint Quattro Secure S MRI™ SureScan™ 693558Recalls & reported problems

Summary

The FDA's MAUDE database contains 278 adverse event reports that list this exact device (DI 00643169690035), received between Apr 6, 2017 and Sep 28, 2026 — classified as 3 deaths, 131 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (107 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 278 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Over-Sensing; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923155 ↗
• InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50828775 ↗
• InjuryAug 18, 2026Break

  It was reported that approximately six weeks post implant, the Implantable Cardioverter Defibrillator (ICD) system was explanted due to infection and replaced more than two weeks later. The patient reported that they were ¿dead when they did it¿ and they were ¿revived¿ with a machine ¿due to a cardiac arrest.¿ The patient alleged that the infection was a result of one of their ¿contaminated leads¿ and stated the leads had ¿corroded.¿ The patient reported that they did a Transesophageal Echocardiogram (TEE) and ¿saw one of the valves had bacteria on it.¿ The patient noted that the bacteria was not there prior to the surgery. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Cardiac Arrest

  MAUDE report 50291873 ↗
• InjuryJul 29, 2026Fracture; High impedance; Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited high out of range pacing and defibrillation impedance and high Sensing Integrity Counter (SIC). All therapies and detections were programmed off due to oversensing of a RV lead fracture. It was noted that the lead was non-functional. The RV lead was inactivated 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 50064160 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) and Right Ventricular (RV) lead were explanted. The reason for explant was not reported. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 50058197 ↗
• MalfunctionJun 30, 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). IT WAS ALSO REPORTED THAT THE LEAD EXHIBITED 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 25668934 ↗
• InjuryJun 23, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC) AND ADDITIONALLY EXHIBITED INTERMITTENT OVERSENSING. PROGRAMMING CHANGES WERE MADE AND 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 25599476 ↗
• MalfunctionJun 16, 2026High impedance; Over-Sensing; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO RV PACING LEAD IMPEDANCE VARIATION AND ELEVATED SENSING INTEGRITY COUNTER (SIC). APPROXIMATELY A YEAR AND A HALF LATER, THE LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH RV 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 25520516 ↗
• MalfunctionMay 19, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR VENTRICULAR TACHYCARDIA (VT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING RESULTING IN REDETECTION OF TACHYARRHYTHMIA. THE ICD AND RV LEAD 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 25219753 ↗
• MalfunctionMay 13, 2026Over-Sensing

  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. 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 25163288 ↗
• InjuryMay 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR PACE. RE-PROGRAMMING WAS DONE ON THE LEAD, BUT THERE WAS FURTHER TWOS. FURTHER RE-PROGRAMMING WAS DONE, AND FURTHER TWOS WAS NOTED. 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 25096057 ↗
• MalfunctionMay 4, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE-NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC) IN ADDITION TO 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 25070514 ↗
• MalfunctionApr 9, 2026Impedance Problem

  IT WAS REPORTED THAT THERE WAS A GRADUAL RISE IN RIGHT VENTRICULAR (RV) LEAD 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 24829151 ↗
• MalfunctionApr 3, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR UNDEFINED OUT OF RANGE HIGH SUPERIOR VENA CAVA (SVC) IMPEDANCE THAT HAD CHANGED ABRUPTLY. 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 24779547 ↗
• MalfunctionApr 1, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED OVERSENSING RESULTING IN T-WAVE OVERSENSING (TWOS). 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 24752719 ↗
• MalfunctionMar 30, 2026Over-Sensing; Unstable Impedance

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO PACING IMPEDANCE VARIATION AND SENSING INTEGRITY COUNTER (SIC). THE RIGHT VENTRICULAR (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 24715512 ↗
• MalfunctionMar 17, 2026Over-Sensing

  IT WAS REPORTED THAT THE STORED EPISODE HAD DOUBLE COUNTED VENTRICULAR FIBRILLATION (VF) WAVES BUT DID NOT APPEAR TO AFFECT DEVICE PERFORMANCE AT THE TIME OF THE CALL. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH-RATE, NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. ADDITIONALLY, IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. BOTH 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 24621396 ↗
• InjuryMar 13, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED LOW VOLTAGE FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. HOWEVER, DURING THE RV LEAD EXPLANT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED SO THAT LEAD WAS ALSO 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 24594081 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 24548995 ↗
• MalfunctionFeb 4, 2026High impedance

  IT WAS REPORTED THAT A LEAD ALERT TRIGGERED DUE TO AN OUT OF RANGE LEAD IMPEDANCE MEASUREMENT. A REVIEW OF THE DEVICE DATA BY QUALIFIED PERSONNEL DETERMINED THAT THERE WAS A SUSPECTED INTEGRITY ISSUE WITH THE RIGHT VENTRICULAR (RV) COIL. 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 24258722 ↗
• MalfunctionJan 30, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE HEARING AN ALERT FOUR TIMES A DAY. THE ALERT CADENCE WAS INDICATIVE OF A POSSIBLE RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT. 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 24223276 ↗
• MalfunctionJan 26, 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 24185275 ↗
• MalfunctionJan 6, 2026Over-Sensing

  IT WAS REPORTED THAT A PARTIAL ELECTRICAL RESET OCCURRED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE AND THE RIGHT VE NTRICULAR (RV) LEAD EXHIBITED SHORT V-V INTERVALS, CAUSING THE SENSING INTEGRITY COUNTER (SIC) TO INCREMENT. THE DEVICE AND 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 23975659 ↗
• MalfunctionDec 30, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AT THE TIME OF IMPEDANCE TESTING. 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 23926936 ↗
• InjuryDec 18, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED OVERSENSING NOISE.

  Patient problems: Fatigue

  MAUDE report 23843276 ↗