Sprint Quattro Secure® 6947M62 (UDI 00643169082267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,158 adverse event reports that list this exact device (DI 00643169082267), received between Dec 9, 2013 and Sep 30, 2026 — classified as 18 deaths, 702 injuries, 438 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (439 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,158 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954786 ↗
• MalfunctionSep 30, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951828 ↗
• InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Right Ventricular (RV) lead was capped and replaced for unknown reasons. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946484 ↗
• InjurySep 29, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  Patient problems: Palpitations

  MAUDE report 50941150 ↗
• InjurySep 24, 2026Capturing Problem

  It was reported that the Right Ventricular (RV) lead was capped due to Rising RV Thresholds and remains in the patient. A new RV lead was implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884268 ↗
• MalfunctionSep 23, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873583 ↗
• InjurySep 23, 2026High impedance; Impedance Problem; Unstable Impedance

  It was reported that the Right Ventricular (RV) lead was capped, and remains in the patient due to High RV Coil Impedance, Spike RV Coil Impedance, Rising RV Coil Impedance, Varying RV Coil Impedance, High SVC Coil Impedance, Spike SVC Coil Impedance and Rising SVC Coil Impedance. It was noted that a lead warning triggered for the SVC Coil and RV Coil impedance issues. It was also reported that a warning triggered for RV tip to RV coil high/undefined impedance A new RV lead was implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871856 ↗
• MalfunctionAug 28, 2026Capturing Problem; Unstable Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508249 ↗
• InjuryAug 27, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing, noise, oversensing resulting in false detection of arry thmia and shock being delivered. A Lead Integrity Alert (LIA) occurred for Sensing Integrity Counter (SIC) and High Rate Non-Sustained episodes. It was reported that the patient was in Coronary Artery Bypass Graft procedure during the time of the episodes and it was unclear if a magnet was placed. The 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 50478640 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to an infection. No further patient c omplications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50350105 ↗
• MalfunctionAug 19, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50323494 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to an infection and erosion. A new ICD system was implanted four days later. No further patient complications have been reported as a result of this event.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50132860 ↗
• InjuryAug 3, 2026Decreased Sensitivity; Capturing Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited rising thresholds and diminished sensing. The RV lead was capped, and remains in the patient. A new RV lead was implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50119784 ↗
• MalfunctionJul 27, 2026Signal Artifact/Noise; Over-Sensing; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50038606 ↗
• MalfunctionJul 10, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING. 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 25782482 ↗
• InjuryJul 10, 2026Signal Artifact/Noise; Over-Sensing; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND PACING IMPEDANCE VARIATION. IT WAS ALSO REPORTED THAT THE LEAD EXHIBITED NOISE AND OVERSENSING. ADDITIONALLY, THE LEAD HAD A SUSPECTED FRACTURE ON THE LOW VOLTAGE TIP. 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 25781196 ↗
• DeathJul 8, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT WITH A SINGLE-CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS DECEASED FOLLOWING CARDIAC ARREST WHERE AN EPISODE OF VENTRICULAR FIBRILLATION (VF) WAS NOT SUCCESSFULLY TERMINATED. REVIEW OF THE EPISODE AND THERAPY DATA INDICATED SIX HIGH-VOLTAGE DEFIBRILLATION SHOCKS WERE ATTEMPTED TO BE DELIVERED, HOWEVER SHORT CIRCUIT PROTECTION (SCP) WAS TRIGGERED DURING THE FIRST PHASE OF HIGH-VOLTAGE THERAPY DELIVERY FOR ALL SIX SHOCKS. THE SCP EVENTS RESULTED IN LESS THAN THE PROGRAMMED HIGH-VOLTAGE ENERGY OR NO HIGH-VOLTAGE ENERGY BEING DELIVERED WHICH FAILED TO TERMINATE THE RHYTHM. REVIEW OF HISTORICAL DEVICE DATA SHOWED NO EVIDENCE ON LEAD TRENDS SUGGESTIVE OF A RIGHT VENTRICULAR (RV) LEAD ISSUE THAT WOULD HAVE CAUSED THE SCP EVENTS. BASED ON THE AVAILABLE DATA, IT WAS NOT POSSIBLE TO DETERMINE WHICH PART OF THE ICD SYSTEM TRIGGERED SCP DURING HIGH-VOLTAGE THERAPY DELIVERY.

  Patient problems: Cardiac Arrest; Ventricular Fibrillation

  MAUDE report 25751974 ↗
• MalfunctionJun 26, 2026Decreased Sensitivity

  IT WAS REPORTED THAT WHILE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PROGRAMMED TO MAGNETIC RESONANCE IMAGING (MRI) MODE WITH ASYNCHRONOUS PACING AND VENTRICULAR DETECTIONS DISABLED, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF). BEING IN MRI MODE RESULTED IN DELAY OF THERAPY AND INAPPROPRIATE PACING. THE DEVICE WAS PROGRAMMED OUT OF MRI MODE AND THE EPISODE WAS DETECTED AND SUCCESSFULLY TREATED WITH HIGH VOLTAGE THERAPY. THE ICD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RESULTING IN UNNECESSARY PACING AT TIMES. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASING R-WAVE MEASUREMENTS. THE RV 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

  MAUDE report 25633398 ↗
• InjuryJun 22, 2026Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE HIGH VOLTAGE THERAPY AND PACING DUE TO RIGHT VENTRICULAR (RV) LEAD T-WAVE OVERSENSING (TWOS) THAT RESULTED IN EPISODE MISCLASSIFICATION. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE ATRIAL PACING. THE RV AND RA LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25580231 ↗
• InjuryJun 17, 2026Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE HIGH VOLTAGE PORTION OF THE RIGHT VENTRICULAR (RV) COIL AND SUPERIOR VENA CAVA (SVC) COIL WERE SUSPECTED TO BE FRACTURED. THE RV LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). IT WAS ALSO NOTED THAT THE RV EXHIBITED HIGH OUT OF RANGE (OOR) PACING, DEFIBRILLATION, AND SVC IMPEDANCE MEASUREMENTS. THE RV LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25541275 ↗
• MalfunctionJun 8, 2026Fracture; High impedance

  IT WAS REPORTED BY THE PATIENT THAT THEIR LEADS WERE FRACTURED. 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 25434223 ↗
• MalfunctionJun 4, 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 25398739 ↗
• MalfunctionMay 28, 2026Signal Artifact/Noise; Over-Sensing; Under-Sensing; Low impedance; Decreased Sensitivity; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED OUT OF RANGE (OOR) LOW PACING IMPEDANCE. THE LEAD ALSO TRIGGERED LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES AND ALSO EXHIBITED NON- PHYSIOLOGIC INTERVALS OR NOISE, DIMINISHED SENSING AND OVERSENSING THAT RESULTED IN MISCLASSIFICATION OF EPISODE TYPE. 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 25319346 ↗
• MalfunctionMay 20, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR PACING. 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 25231835 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25223636 ↗