Sprint Quattro Secure S® 6935M55 (UDI 00613994718839)Recalls & reported problems

Summary

The FDA's MAUDE database contains 449 adverse event reports that list this exact device (DI 00613994718839), received between Oct 10, 2013 and Sep 11, 2026 — classified as 2 deaths, 297 injuries, 150 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (209 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 25 most recent of 449 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740599 ↗
• MalfunctionSep 4, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613890 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to an infection. It was noted that the infection growth was seen on the Right Ventricular (RV) lead and there was also vegetation on the RV lead. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50483030 ↗
• MalfunctionAug 18, 2026Over-Sensing; Low impedance; Unstable Impedance

  It was further reported that the RV lead was reprogrammed and remains in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306975 ↗
• InjuryAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient's 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 50234079 ↗
• MalfunctionJun 30, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS DUE TO HIGH OUT OF RANGE (OOR) PACING IMPEDANCE MEASUREMENTS. 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 25673852 ↗
• MalfunctionJun 10, 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 25462265 ↗
• MalfunctionMay 19, 2026Fracture

  THE RIGHT VENTRICULAR (RV) LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224807 ↗
• InjuryMay 13, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EXHIBITED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE-NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS FURTHER REPORTED THAT THERE WAS OVERSENSING RESULTING IN INHIBITION OF PACING IN ADDITION TO INAPPROPRIATE SHOCK AND NON-PHYSIOLOGIC INTERVALS AND NOISE. OF NOTE, THE PATIENT HAD AN UNSPECIFIED PROCEDURE ON THAT DAY WHICH POSSIBLY CORRELATED WITH THE TIME OF OVERSENSING AND SHOCKS. 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 25165051 ↗
• InjuryMay 11, 2026Over-Sensing; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. RISING AND VARIABLE PACING IMPEDANCE WAS NOTED IN ADDITION TO VARIABLE DEFIBRILLATION COIL IMPEDANCE. THE LEAD WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25139169 ↗
• MalfunctionApr 24, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH UNDEFINED IMPEDANCES. 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 24984702 ↗
• InjuryMar 30, 2026Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SPIKE AND HIGH OUT OF RANGE DEFIBRILLATION IMPEDANCE. THE RV COIL WAS SUSPECTED TO BE FRACTURED. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717030 ↗
• InjuryMar 10, 2026Fracture

  IT WAS REPORTED THAT THERE WAS A SUSPECTED FRACTURE OF THE HIGH VOLTAGE COIL OF THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559730 ↗
• InjuryMar 4, 2026High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH TIP TO COIL IMPEDANCE, OVERSENSING AND SUDDEN INCREMENTING OF SENSING INTEGRITY COUNTER (SIC) WITH RELATED LEAD INTEGRITY ALERT (LIA). SUBSEQUENTLY, THE RV LEAD WAS INACTIVATED AND A NEW RV LEAD WAS IMPLANTED. THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING OF ATRIAL PACING. THE RA 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 24506872 ↗
• MalfunctionFeb 23, 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 24414436 ↗
• MalfunctionFeb 20, 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 24403269 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND THEN REPLACED A SIX DAYS LATER DUE TO ENDOCARDITIS ON THE RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 24223968 ↗
• InjuryJan 27, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24187318 ↗
• MalfunctionJan 16, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR  LOW PACING IMPEDANCE. THE ALERT TONE WAS PROGRAMMED OFF AND 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 24094338 ↗
• InjuryJan 14, 2026Intermittent Capture; Fracture; High impedance; Impedance Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WAS HEARING A LEAD INTEGRITY ALERT (LIA) AND THE PATIENT CONFIRMED IT WAS HAPPENING EVERY FOUR HOURS. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED LOW VOLTAGE FRACTURE. ADDITIONALLY, IT WAS NOTED THAT THE LEAD EXHIBITED VARYING AND HIGH PACING IMPEDANCE, HIGH AND UNSTABLE THRESHOLDS, AND INTERMITTENT CAPTURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070039 ↗
• InjuryJan 9, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE PACING IMPEDANCE, NOISE, AND SHORT V-V INTERVALS. THERE WAS ALSO REPORTED TO BE A FRACTURE ON THE LOW VOLTAGE PORTION OF THE LEAD. THE PATIENT NOTED THAT THEY HAD A FALL "A COUPLE" OF MONTHS AGO BY TRIPPING AND FALLING OFF THEIR PORCH. 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 24028024 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 23991837 ↗
• MalfunctionJan 5, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED AN ALERT FOR LOW, OUT-OF-RANGE 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 23961123 ↗
• DeathJan 2, 2026Under-Sensing

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. A REVIEW OF A REMOTE TRANSMISSION FROM THE DATE OF DEATH INDICATED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND NO CAPTURE. ADDITIONALLY, THE RA LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH PACING IMPEDANCE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OCCASIONAL UNDERSENSING DURING FINE VENTRICULAR EVENTS ON TREATED EPISODES. A CAUSE OF DEATH HAS BEEN REQUESTED BUT NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 23950367 ↗
• MalfunctionDec 23, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO NOTED THAT THE PATIENT REPORTED HEARING A HIGH URGENCY TONE FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MULTIPLE TIMES IN ONE DAY. 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 23877771 ↗