Sprint Quattro™ MRI SureScan™ 6946M55Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00643169858305), received between Apr 10, 2018 and Sep 11, 2026 — classified as 2 deaths, 20 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (12 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50739321 ↗
• MalfunctionAug 31, 2026High Capture Threshold

  It was reported that the Right Ventricular (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 50529228 ↗
• InjuryJun 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE USE OF CAUTERY. OVERSENSING OF NON-PHYSIOLOGICAL NOISE/EMI TRIGGERED WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC) DURING THE PROCEDURE. IT WAS NOTED THAT A MAGNET WAS PLACED ON THE CRT-D BRIEFLY AT THE PRIOR TO THE PROCEDURE AND WAS THEN REMOVED. THE CRT-D AND RV LEAD 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 25659995 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE A FEVER AND BACTEREMIA. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED APPROXIMATELY 2 WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Fever

  MAUDE report 24714619 ↗
• MalfunctionSep 16, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT DUE TO HIGH OUT OF RANGE (OOR) PACING IMPEDANCE. IT WAS NOTED THAT THERE WAS A GRADUAL RISE IN 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 23066356 ↗
• MalfunctionSep 9, 2025Under-Sensing; Under-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 23008803 ↗
• MalfunctionAug 13, 2025Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING. NOISE AND NON-PHYSIOLOGIC OVERSENSING INCLUDING PACING I NHIBITION WAS ALSO OBSERVED. A FRACTURE WAS SUSPECTED. 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 22800601 ↗
• MalfunctionJul 1, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT TWO DAYS POST IMPLANT, THERE WAS A DECREASE IN PACING IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD, AND LEFT VENTRICULAR (LV) LEAD. ALSO, THE RV LEAD HAD A DECREASE IN SUPERIOR VENA CAVA (SVC) AND RV COIL IMPEDANCES. 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 22378078 ↗
• InjuryJun 3, 2025Positioning Problem; High Capture Threshold; Positioning Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED POSITIONAL NON-CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED DURING AN UPGRADE TO A BI-VENTRICULAR DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22131680 ↗
• MalfunctionMay 30, 2025Break; Mechanical Problem; Activation, Positioning or Separation Problem; Break; Mechanical Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING IMPLANT, THERE WAS RESISTANCE INSERTING THE RIGHT VENTRICULAR (RV) LEAD AND IT APPEARED TO BE AN ISSUE WITH THE SUPERIOR VENA CAVA (SVC) COIL. THE LEAD HAD INSULATION DAMAGE/BREACH. THE LEAD WAS REMOVED, AND A NEW 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 22116446 ↗
• InjuryJan 2, 2025Signal Artifact/Noise; Fracture; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Fracture; Over-Sensing; Impedance Problem

  IT WAS REPORTED BY THE PATIENT'S SON THAT THE PATIENT WAS OUT OF THE COUNTRY AND THE DEVICE WAS ALARMING EVERY FOUR HOURS. A REMOTE MONITORING TRANSMISSION INDICATED THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). WHEN THE PATIENT RETURNED HOME, IT WAS NOTED THAT THE PACING IMPEDANCE WAS VARYING AND RISING. NOISE WAS ALSO OBSERVED ON THE RV LEAD. A FRACTURE OF THE LOW VOLTAGE PORTION OF THE RV LEAD WAS SUSPECTED AND 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 21055294 ↗
• MalfunctionAug 15, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT EPISODES SHOWED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSE (VS). THE RIGHT VENTRICULAR (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 19991874 ↗
• MalfunctionJul 5, 2024Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD BOTH INTERMITTENT UNDERSENSING AND INTERMITTENT OVERSENSING. 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 19682197 ↗
• MalfunctionJul 2, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT SIX DAYS POST IMPLANT THE PATIENT EXPERIENCED SYNCOPE. UPON REVIEW OF THE DEVICE TRANSMISSION IT WAS NOTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD UNDERSENSING NOTED AND P WAVES WERE NOT BEING SENSED ON THE PRESENTING ELECTROGRAM (EGM). TWO DAYS LATER IT WAS NOTED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL, RA LEAD SENSITIVITY HAD BEEN REPROGRAMMED AND THERE WAS NO UNDERSENSING NOTED ON THE PRESENTING EGM. IT WAS ALSO LATER NOTED THAT RIGHT VENTRICULAR (RV) LEAD THRESHOLDS WERE HIGH. THE RA AND RV LEADS REMAIN 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 19661450 ↗
• MalfunctionMar 11, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT ONE DAY POST IMPLANT, RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENTS BIPOLAR AND TIP TO COIL WITH A SIGNIFICANT DECLINE.  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 18874722 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 18754651 ↗
• InjuryJan 8, 2024Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). RECORDED EPISODES SHOWED CLEAR EVIDENCE OF NOISE ON THE RV TIP TO RV RING ELECTROGRAMS (EGM) AND AN SUPERIOR VENA CAVA (SVC) COIL FRACTURE WAS SUSPECTED. THE LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465222 ↗
• MalfunctionDec 5, 2023Failure to Capture; Impedance Problem; High Capture Threshold; Failure to Capture; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED A WARNING FOR HIGH UNDEFINED IMPEDANCE AND EXHIBITED A HIGH THRESHOLD.  THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASING IMPEDANCE AND HIGH THRESHOLDS.  CAPTURE WAS UNABLE TO BE CONFIRMED ON THE LV LEAD AND RV LEAD. THE RV 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 18270598 ↗
• MalfunctionOct 23, 2023High impedance; Impedance Problem; High Capture Threshold; High impedance; Impedance Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION. THE RV LEAD EXHIBITED AN INCREASE IN RV PACING IMPEDANCE OVER THE PAST SIX MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987033 ↗
• MalfunctionAug 24, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD AS THERE WERE THREE HIGH RATE NON-SUSTAINED EPISODES AND AN INCREASE IN SIC (SENSING INTEGRITY COUNTER). 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 17618489 ↗
• DeathJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POCKET INFECTION WAS DIAGNOSED A FEW MONTHS POST-CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IMPLANT. THE CRT-D SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Disseminated Intravascular Coagulation (DIC); Unspecified Infection

  MAUDE report 17259626 ↗
• InjuryMay 25, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS FURTHER REPORTED THAT THERE HAD ALSO BEEN NOISE OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED, AND THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 17002418 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Hematoma

  MAUDE report 15993175 ↗
• InjuryOct 14, 2022High impedance; Capturing Problem; Impedance Problem; High Capture Threshold; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD RISING PACING IMPEDANCE AND RISING RV THRESHOLDS THAT BECAME HIGH. THE LEAD REMAINS IN USE AND WILL CONTINUE TO BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607241 ↗
• DeathFeb 14, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT IS DECEASED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIFFICULTY BREATHING DURING THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM IMPLANT PROCEDURE. THE PATIENT WAS INTUBATED AND TAKEN TO THE INTENSIVE CARE UNIT (ICU) AFTER THE PROCEDURE. THAT EVENING THAT PATIENT WENT TO DIALYSIS. DURING DIALYSIS, THE PATIENT BECAME HEMODYNAMICALLY COMPROMISED RESULTING IN A CODE SITUATION AND DEATH.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 13522714 ↗