Sprint Quattro Secure MRI™ SureScan™ 694758Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00643169692374), received between Jun 8, 2017 and Sep 16, 2026 — classified as 1 death, 74 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (57 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 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793361 ↗
• InjuryJul 29, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited oversensing. The RV lead was capped, remains in the patient and 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 50074887 ↗
• MalfunctionApr 16, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSED BEATS ON STORED EPISODES. 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 24895790 ↗
• MalfunctionMar 25, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING RESULTING IN RESULTING IN 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 24690674 ↗
• InjuryMar 10, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED FRACTURE IN THE LOW VOLTAGE PORTION. THE LEAD WAS SUBSEQUENTLY 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 24558720 ↗
• InjuryFeb 9, 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 24300462 ↗
• InjuryJan 22, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) RESULTING IN INAPPROPRIATE THERAPY BEING DELIVERED. 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 24145721 ↗
• MalfunctionDec 19, 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 23856425 ↗
• MalfunctionDec 9, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH-RATE, NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. IT WAS ALSO NOTED THAT THE LEAD EXHIBITED OVERSENSING AND POSSIBLE NOISE. 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 23759487 ↗
• InjuryNov 13, 2025Fracture; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Fracture; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING RV PACING IMPEDANCE, HAD A SUSPECTED HIGH VOLTAGE COIL FRACTURE, CAUSING INAPPROPRIATE THERAPY. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23545204 ↗
• MalfunctionNov 4, 2025Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). THE DEVICE DISCRIMINATOR STOPPED WITHHOLDING THERAPY, POSSIBLY DUE TO NOISE ON THE RIGHT VENTRICULAR CHANNEL. THE ICD AND RIGHT VENTRICULAR (RV) LEAD 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 23465061 ↗
• InjuryOct 30, 2025Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE PHYSICIAN CONFIRMED THAT THE RV COIL HAD HIGH IMPEDANCES AS THE SVC COIL HAD BEEN TURNED OFF AND THE RV COIL CONTINUED TO HAVE HIGH IMPEDANCES. THE PHYSICIAN ALSO CONFIRMED THAT THERE WAS NOTHING MECHANICALLY WRONG WITH THE LEAD; IT WAS SIMPLY PLACED IN THE CORONARY SINUS BODY ANTERIOR LYING IN A POSSIBLE DIAGONAL VEIN AND THOUGHT A DIFFERENT LEAD AND POSITION WOULD WORK BETTER PHYSIOLOGICALLY FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429971 ↗
• DeathOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT¿S FAMILY MEMBER THAT THE PATIENT HAD THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXPLANTED APPROXIMATELY 5 WEEKS POST IMPLANT BECAUSE THE PATIENT¿S BODY WAS "REJECTING" THE ICD SYSTEM. THE PATIENT¿S FAMILY MEMBER DESCRIBED THE INFECTION AS THE WHOLE AREA WAS INFECTED, GROSS LOOKING, AND TURNING BLACK. THEY ALSO NOTED THAT THE INFECTION WAS IN THE PATIENT¿S BLOOD STREAM BUT THE PATIENT ALSO HAD AN INFECTION POSSIBLE PRIOR TO DEVELOPING THE DEVICE RELATED INFECTION. ADDITIONALLY, THE PATIENT¿S FAMILY MEMBER STATED THAT THE PATIENT IS DECEASED AND HAD PASSED AWAY ON (B)(6) 2025, WHICH WAS APPROXIMATELY 6 WEEKSPOST EXPLANT OF THE PATIENT¿S ICD SYSTEM. THE PATIENT¿S CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23322472 ↗
• MalfunctionAug 27, 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 22905998 ↗
• InjuryJul 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A CONFIRMED FRACTURE IN THE LOW VOLTAGE PORTION. THE LEAD WAS SUBSEQUENTLY 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 22607877 ↗
• InjuryJul 24, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE RV AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL IMPEDANCE AND ERRATIC COIL IMPEDANCE. 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 22592471 ↗
• InjuryJul 23, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE ATRIAL LEAD THAT LED TO MISCLASSIFICATION OF SUPRA VENTRICULAR TACHYCARDIA (SVT) AND WITHHOLDING OF THERAPY. IN ADDITION, THERE WAS POSSIBLE UNDERSENSING OF R-WAVES THAT RESULTED IN FALSE DETECTION OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT). THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 22579010 ↗
• MalfunctionJul 11, 2025Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). IN ADDITION, THERE WAS INTERMITTENT RV OVERSENSING AND UNDERSENSING OBSERVED ON STORED ELECTROGRAMS. 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 22482864 ↗
• MalfunctionJun 9, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH 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 22168570 ↗
• InjuryMay 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE LOW VOLTAGE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. 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 22100865 ↗
• InjuryApr 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867436 ↗
• MalfunctionFeb 13, 2025Under-Sensing; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC AND AT THE TIME THE PATIENT WAS ILL AND WITHHOLDING BETA BLOCKERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378827 ↗
• MalfunctionFeb 3, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH 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 21297825 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REDNESS, SWELLING, PURULENT DISCHARGE AND PUS AROUND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET DUE TO A SUSPECTED INFECTION. IT WAS NOTED THAT THE DEVICE WAS IMPLANTED WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE CRT-D SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 21159328 ↗
• MalfunctionJan 7, 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 21091496 ↗