Sprint Quattro™ MRI SureScan™ 6946M62Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00643169858329), received between Aug 1, 2018 and Sep 4, 2026 — classified as 1 death, 71 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (51 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Low impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616648 ↗
• InjurySep 2, 2026Signal Artifact/Noise; Fracture; Over-Sensing; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569820 ↗
• MalfunctionAug 25, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited high capture 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 50428061 ↗
• InjuryAug 24, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Unstable Impedance

  It was reported that the Right Ventricular (RV) lead had a suspected low voltage fracture. A Lead Integrity Alert (LIA) had triggered for High Rate Non-Sustained episodes and RV lead pacing impedance variation. The patient was then admitted to the hospital for review of the RV lead. It was then noted that multiple LIAs triggered for High Rate Non-Sustained episodes and short ventricular intervals. It was also noted that the RV lead exhibited high, undefined pacing impedance, oversensing in non-physiologic intervals/noise, and oversensing resulting in the misclassification of episode type and inhibition of pacing. Additionally, it was noted that the patient received possibly inappropriate therapy due to RV lead oversensing resulting in Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) detection. 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

  MAUDE report 50418912 ↗
• InjuryAug 3, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to High Rate Non-Sustained episodes and the Sensing Integrity Counter (SIC) being incremented. 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 50122275 ↗
• InjuryJun 23, 2026Signal Artifact/Noise; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED DUE TO AN AUDIBLE ALERT. A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. OVERSENSING HAD RESULTED IN THE MISCLASSIFICATION OF EPISODES AS NON-SUSTAINED VENTRICULAR TACHYCARDIA OR HIGH RATE NON-SUSTAINED EPISODES. NOISE AND CROSS-CHAMBER OVERSENSING WERE ALSO OBSERVED. PROGRAMMING CHANGES WERE MADE TO THE LEAD. THE PATIENT RETURNED THE NEXT DAY AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO THE OVERSENSING AND SUSPECTED LEAD FRACTURE. THE RV LEAD WAS CAPPED AND THE PATIENT WAS FITTED WITH A LIFEVEST UNTIL THE PATIENT COULD HAVE A LASER LEAD REMOVAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25597477 ↗
• MalfunctionJun 4, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HISTORICALLY HIGH CAPTURE THRESHOLDS WITH HIGH OUTPUTS. ADDITIONALLY, STORED EPISODES REVEALED UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE RV AND RA 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 25399362 ↗
• MalfunctionMay 4, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. 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 25073062 ↗
• MalfunctionApr 22, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SENSING INTEGRITY COUNTER (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 24959348 ↗
• MalfunctionApr 2, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD CAPTURE COULD NOT BE CONFIRMED, ALONG WITH RIGHT VENTRICULAR (RV) LEAD SENSING. 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 24769278 ↗
• InjuryMar 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT AS ON LIFE SUPPORT WITH SEVERE SEPTIC SHOCK AND ORGAN FAILURE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Multiple Organ Dysfunction Syndrome; Septic Shock

  MAUDE report 24495694 ↗
• InjuryFeb 12, 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24319861 ↗
• MalfunctionFeb 9, 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 24299890 ↗
• MalfunctionJan 30, 2026Impedance Problem

  IT WAS REPORTED THAT SINCE IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED A GRADUAL DECREASE IN 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 24224525 ↗
• MalfunctionJan 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED SHORTLY AFTER IMPLANT. 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 24070026 ↗
• MalfunctionDec 1, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE RV LEAD AND RA LEAD 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 23687699 ↗
• MalfunctionNov 20, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A PARTIAL ELECTRICAL RESET WHERE DIAGNOSTIC DATA SUCH AS PACING PERCENTAGES AND RATE HISTOGRAMS WERE CLEARED, HOWEVER PARAMETER VALUES REMAINED UNCHANGED. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF).THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS AND THE PATIENT EXPERIENCED DIZZINESS. THE ICD SYSTEM REMAINS IN USE NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 23612878 ↗
• MalfunctionOct 28, 2025Capturing Problem; Impedance Problem; High Capture Threshold; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN PACING IMPEDANCE. PACING THRESHOLDS HAD INCREASED SIMULTANEOUSLY AND HAD REACHED A HIGH RANGE. 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 23401021 ↗
• MalfunctionOct 20, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT T-WAVE OVERSENSING (TWOS) WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD AND WAS DETECTED AS NON-SUSTAINED VENTRICULAR TACHYCARDIA IN THE TRANSMISSION. 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 23342483 ↗
• MalfunctionSep 2, 2025Defibrillation/Stimulation Problem; Under-Sensing; Defibrillation/Stimulation Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING, POSSIBLY DELAYING VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) THERAPIES. 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 22938182 ↗
• InjuryAug 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864866 ↗
• MalfunctionAug 20, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED OVERSENSING ON HIGH RATE NON-SUSTAINED EPISODES AND 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 22853653 ↗
• InjuryAug 20, 2025Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT REPROGRAMMING OCCURRED AND THE LEAD SENSITIVITY WAS INCREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853289 ↗
• InjuryAug 15, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. 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 22821753 ↗
• InjuryAug 7, 2025Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING THE PATIENT'S CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, THE PATIENT RECEIVED INAPPROPRIATE THERAPY. A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). IN ADDITION, OVERSENSING AND NOISE WERE REPORTED. THE RIGHT VENTRICULAR (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 22742746 ↗