Sprint Quattro Secure S™ 693575Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994446367), received between Aug 21, 2018 and Dec 10, 2025 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING DURING A TREATED VENTRICULAR FIBRILLATION (VF) EPISODE T HOUGH THERE WAS NO OBSERVED IMPACT TO OVERALL DEVICE FUNCTION OR PERFORMANCE. 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 23771840 ↗
• MalfunctionDec 10, 2025High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT AN ALERT TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD FOR ZERO OHM IMPEDANCE IN ONE CONFIGURATION WHILE ALERTING FOR HIGH UNDEFINED IMPEDANCE ON ANOTHER. THE RIGHT ATRIAL (RA) LEAD ALSO ALERTED FOR ZERO OHM IMPEDANCE. 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 23771772 ↗
• MalfunctionJul 17, 2023High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH DEFIBRILLATION IMPEDANCE. IT WAS NOTED THAT THERE HAD BEEN A SLOW INCREASE IN RV LEAD DEFIBRILLATION IMPEDANCE OVER TIME WITH THE PATIENT'S CHANGING CLINICAL CONDITION. 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 17331964 ↗
• InjuryMar 30, 2023Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT AN AUDIBLE ALERT WAS TRIGGERED. AN INTERROGATION SHOWED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD FOR OVERSENSING OF NOISE ON THE RV CHANNEL AND NOISE DURING HIGH-RATE EVENTS, AND AN OUT OF RANGE (OOR) PACING IMPEDANCE MEASUREMENT WAS OBSERVED THAT WAS LATER CLARIFIED TO BE HIGH/UNDEFINED. THE 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 16644614 ↗
• InjurySep 7, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSE (VS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD RE MAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371397 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 10809605 ↗
• MalfunctionOct 16, 2020Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10690202 ↗
• InjuryJun 30, 2020Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH RV COIL IMPEDANCE. A FRACTURE OF THE RV COIL WAS CONFIRMED. THE RV LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10211876 ↗
• InjuryMar 19, 2020Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD UNDERSENSED ONE R-WAVE IN THE NON-SUSTAINED TACHYCARDIA EPISODE. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9853255 ↗
• MalfunctionFeb 6, 2019Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT RIGHT VENTRICULAR UNDERSENSING WAS NOTED ON STORED ELECTROGRAMS. THE RIGHT VENTRICULAR LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8312774 ↗
• InjuryAug 21, 2018Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold; Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE RIGHT VENTRICULAR (RV) LEAD WHILE ASYMPTOMATIC AND WENT TO THE EMERGENCY ROOM (ER). THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO OVERSENSING OF NOISE WITH HIGH RATE NON-SUSTAINED (HR-NS) AND SENSING INTEGRITY COUNTER (SIC) EPISODES. THE LEAD HAD HIGH IMPEDANCE, HIGH THRESHOLDS WITH LOSS OF CAPTURE, AND A CONFIRMED FRACTURE. A MAGNET WAS PLACED OVER THE DEVICE TO PREVENT ANY FURTHER SHOCKS AND THE LEAD WAS PROGRAMMED OFF. THE LEAD REMAINS IN THE PATIENT OUT OF SERVICE. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS HIGH THRESHOLDS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 7801940 ↗