Sprint Quattro Secure® 6947M55 (UDI 00643169309715)Recalls & reported problems

Summary

The FDA's MAUDE database contains 391 adverse event reports that list this exact device (DI 00643169309715), received between Feb 10, 2015 and Sep 1, 2026 — classified as 4 deaths, 229 injuries, 158 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (154 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 391 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539693 ↗
• MalfunctionAug 14, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50259962 ↗
• MalfunctionJun 15, 2026Low impedance

  IT WAS REPORTED THAT ON THE DAY OF A GENERATOR EXCHANGE, THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR 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 25505010 ↗
• MalfunctionJun 10, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE WARNING FOR LOW  IMPEDANCE.  THE PATIENT HAD EXPERIENCED HYPERVENTILATION. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hyperventilation

  MAUDE report 25462273 ↗
• MalfunctionJun 9, 2026High impedance; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR UNDEFINED HIGH PACING IMPEDANCES AND UNDEFINED HIGH RV DEFIBRILLATION COIL IMPEDANCES. THE RIGHT ATRIAL (RA) LEAD TRIGGERED A WARNING FOR UNDEFINED HIGH PACING IMPEDANCES. THE LEFT VENTRICULAR (LV) LEAD TRIGGERED A WARNING FOR UNDEFINED HIGH PACING IMPEDANCES. IN ADDITION, THE RV LEAD EXHIBITED UNDERSENSING AND THE RA LEAD EXHIBITED OVERSENSING. THE RV, RA AND LV 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 25446535 ↗
• MalfunctionJun 2, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING AND OVERSENSING. THE RV LEAD REMAINS IN US E. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368874 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25023142 ↗
• MalfunctionApr 8, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND A BLANKED BEAT. 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 24821234 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24549954 ↗
• MalfunctionMar 5, 2026Fracture; Over-Sensing; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED FRACTURE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR PACING IMPEDANCE VARIATION AND SENSING INTEGRITY COUNTER (SIC). IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED PACING IMPEDANCE SPIKES. 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 24523659 ↗
• MalfunctionFeb 26, 2026Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN IMPEDANCE ALERT FOR LOW PACING IMPEDANCES. THE RV LEAD PACING IMPEDANCES WERE TRENDING CONSISTENT WITH HISTORICAL VALUES. IN ADDITION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INVALID DATA WITH THE P WAVE TRENDS. THE RV LEAD AND ICD 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 24457962 ↗
• InjuryFeb 19, 2026Signal Artifact/Noise; Fracture; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED FRACTURE ON THE LOW VOLTAGE PORTION OF THE LEAD. IT WAS FURTHER REPORTED THAT MULTIPLE LEAD INTEGRITY ALERTS (LIA) WERE TRIGGERED TO DUE HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS FURTHER REPORTED THAT THE LEAD EXHIBITED NOISE, OVERSENSING AND T-WAVE OVERSENSING (TWOS). THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT WAS PLACED ON A LIFE-VEST. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393015 ↗
• InjuryFeb 9, 2026Fracture; High impedance

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS SUSPECTED TO BE FRACTURED. THE RV LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293845 ↗
• MalfunctionJan 22, 2026High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR HIGH/UNDEFINED BIPOLAR, RVTIP TO RVCOIL IMPEDANCE AND SENSING INTEGRITY COUNTER (SIC).  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 24151868 ↗
• InjuryJan 16, 2026Pacing Problem; Defibrillation/Stimulation Problem; Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT A STORED EPISODE NOTED RIGHT VENTRICULAR (RV) UNDERSENSING DURING ARRYTHMIA RESULTING IN DELAY OF VENTRICULAR T ACHYCARDIA (VT) EPISODE DETECTION, HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING (ATP). IT WAS ALSO NOTED THAT THERE WERE HIGH RV THRESHOLDS. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24104120 ↗
• MalfunctionDec 22, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POTENTIAL T-WAVE OVERSENSING (TWOS). THE LV AND RV 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 23872477 ↗
• InjuryDec 19, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR HIGH, OUT-OF-RANGE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE. THE SVC COIL WAS PROGRAMMED OFF. 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 23850788 ↗
• InjuryDec 18, 2025Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED LOW VOLTAGE FRACTURE. IT WAS ALSO NOTED THAT THE LEAD EXHIBITED HIGH IMPEDANCE AND NO 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 23843713 ↗
• InjuryDec 15, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Appropriate Device Problem Term/Code Not Available; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REPLACED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 23802494 ↗
• InjuryDec 8, 2025Signal Artifact/Noise; Break; Collapse; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Break; Collapse; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS FURTHER REPORTED THAT THE LOW VOLTAGE PORTION OF THE LEAD WAS FRACTURED AND EXHIBITED SIGNS OF CLAVICULAR LEAD CRUSH.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23745057 ↗
• InjuryDec 1, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS PROGRAMMED TO EXTENDED BIPOLAR AND WAS SENSING ATRIAL ACTIVITY CAUSING OVERSENSING AND PAUSES. THE PATIENT WAS SYNCOPAL, SO A TEMPORARY PACING WIRE WAS IMPLANTED. A DEVICE CHANGEOUT PROCEDURE WAS DONE AND THE PARAMETERS ON THE LEAD WERE REPROGRAMED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes; Syncope/Fainting

  MAUDE report 23687125 ↗
• MalfunctionNov 24, 2025Over-Sensing; Over-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 23633608 ↗
• MalfunctionNov 12, 2025High impedance; Over-Sensing; Low impedance; High impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING DURING ARRHYTHMIA DETECTION, HIGH PACING IMPEDANCE, LOW DEFIBRILLATION IMPEDANCE, AND A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED 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 23533349 ↗
• InjuryNov 11, 2025Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND RISING PACING IMPEDANCE. 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 23528344 ↗
• MalfunctionNov 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED PACING IMPEDANCE. THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING, TRIGGERING FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH INAPPROPRIATE ATRIAL PACING AND IMPACTING MODE SWITCH. 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 23450488 ↗