Sprint Quattro Secure® 6947M62 (UDI 00643169309722)Recalls & reported problems

Summary

The FDA's MAUDE database contains 796 adverse event reports that list this exact device (DI 00643169309722), received between Dec 9, 2016 and Sep 30, 2026 — classified as 10 deaths, 491 injuries, 295 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (337 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 796 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Low impedance; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited undefined low pacing impedance. It was also noted that the RV lead exhibited high thresholds. 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 50948547 ↗
• InjurySep 28, 2026Fracture

  It was reported that the Right Ventricular (RV) lead had a confirmed high-voltage fracture. 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 50917371 ↗
• InjurySep 25, 2026Fracture

  It was reported that there was a low voltage fracture on the Right Ventricular (RV) lead. 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 50897285 ↗
• MalfunctionSep 24, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50890298 ↗
• MalfunctionSep 17, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812450 ↗
• MalfunctionSep 11, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737129 ↗
• InjurySep 10, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS). The lead was reprogrammed and 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 50714289 ↗
• InjuryAug 26, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that during use of the Right Ventricular (RV) lead the patient received Inappropriate shock. The RV lead was capped, remains in the patient and a new RV lead was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50455746 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced due to infection. The patient was experiencing discomfort, redness, and swelling. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 50354407 ↗
• MalfunctionAug 17, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited intermittent oversensing on a stored episode. 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 50278337 ↗
• MalfunctionAug 7, 2026Over-Sensing; Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50169195 ↗
• MalfunctionJun 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 25548766 ↗
• MalfunctionJun 16, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 25523050 ↗
• MalfunctionJun 11, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) 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 25480610 ↗
• MalfunctionJun 11, 2026Fracture; High impedance; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR UNDEFINED HIGH SUPERIOR VENA CAVA (SVC) 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 25471404 ↗
• MalfunctionJun 1, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR UNDEFINED LOW RV PACING IMPEDANCE. THE VALUE HAS SINCE RETURNED TO EXPECTED VALUES, 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 25350867 ↗
• MalfunctionMay 28, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND AN ELEVATED NUMBER OF NON-PHYSIOLOGIC/SENSING INTEGRITY COUNTERS (SIC). 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 25318750 ↗
• MalfunctionMay 21, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSED BEATS. 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 25243423 ↗
• InjuryMay 21, 2026Signal Artifact/Noise; Intermittent Capture; Fracture; Over-Sensing; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE LOW VOLTAGE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD HAD FRACTURED. A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. THE LEAD EXHIBITED INTERMITTENT CAPTURE, NOISE, UNDERSENSING, T-WAVE OVERSENSING (TWOS), AND DIMINISHING R-WAVES. THE SYSTEM WAS INACTIVATED AND AN EXTRAVASCULAR SYSTEM WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25239366 ↗
• MalfunctionMay 11, 2026Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; High Capture Threshold; Unstable Impedance

  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). THE LEAD EXHIBITED NOISE AND OVERSENSING RESULTING IN INHIBITION OF PACING. ADDITIONALLY, THE LEAD EXHIBITED VARYING AND UNDEFINED HIGH PACING IMPEDANCE AS WELL AS HIGH THRESHOLDS WITH LOSS OF CAPTURE. 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 25142263 ↗
• MalfunctionMay 6, 2026Over-Sensing

  FOLLOW UP WITH THE CLINIC INDICATED THE TWOS WAS AN ISOLATED EVENT AND THE PATIENT WOULD CONTINUE TO BE MONITORED. NO FURTHER ACTIONS WERE TAKEN AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25096072 ↗
• MalfunctionMay 5, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS INCREASED. 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 25088804 ↗
• MalfunctionMay 5, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN UNDERSENSED BEAT DURING 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 25088748 ↗
• MalfunctionMay 4, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR RV COIL IMPEDANCE OUT OF RANGE (OOR). 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 25072876 ↗
• MalfunctionApr 27, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND OVERSENSING. IT WAS ALSO REPORTED THAT THE RIGHT VEN TRICULAR (RV) LEAD TRIGGERED A LEAD NOISE WARNING, SHOWING 24 SHORT V-V INTERVALS, EXHIBITED OVERSENSING, EXHIBITED UNDERSENSING, AND TRIGGERED A TIP TO COIL OUT OF RANGE (OOR) LOW PACING IMPEDANCE WARNING. 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 25001135 ↗