Sprint Quattro Secure MRI™ SureScan™ 694765Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00643169692381), received between Apr 6, 2017 and Sep 8, 2026 — classified as 1 death, 62 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (41 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 114 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited noise, oversensing, and non-physiologic/Sensing Integrity Counter (SIC). The RV 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 50672761 ↗
• MalfunctionJun 30, 2026Over-Sensing

  IT WAS REPORTED THAT STORED EPISODES REVEALED T-WAVE OVERSENSING (TWOS). 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 25665095 ↗
• InjuryJun 5, 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 POCKET INFECTION. IT WAS NOTED THAT THE PATIENT EXPERIENCED PURULENT DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Purulent Discharge

  MAUDE report 25417943 ↗
• MalfunctionMay 13, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD NOISE WARNING AND A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND THE SENSING INTEGRITY COUNTER (SIC) BEING INCREMENTED. THE RV LEAD ALSO EXHIBITED OVERSENSING BEFORE AND AFTER DETECTION, RESULTING IN EARLIER CLASSIFICATION OF EPISODE TYPE AND OVERSENSING BEFORE DETECTION, RESULTING 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 25162421 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25001310 ↗
• InjuryDec 17, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SUPERIOR VENA CAVA (SVC) AND RV COIL IMPEDANCE AND A HIGH VOLTAGE RV COIL/SVC COIL FRACTURE WAS SUSPECTED. THE RV 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 23828147 ↗
• MalfunctionDec 15, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING BEFORE DETECTION OF VENTRICULAR TACHYCARDIA (VT) EPISODES. A LEAD INTEGRITY ALERT (LIA) HAD ALSO TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. 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 23805181 ↗
• MalfunctionDec 8, 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 23743653 ↗
• InjuryNov 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CONFIRMED FRACTURE OF THE LOW VOLTAGE VECTOR. 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 23656938 ↗
• InjuryNov 19, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). 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 23596398 ↗
• InjuryNov 4, 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 SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE LEAD EXHIBITED OVERSENSING AND NOISE. THE RV LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WERE 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 23466500 ↗
• MalfunctionOct 31, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED UNDERSENSING OF 2 BEATS ON STORED EPISODES OF VENTRICULAR FIBRILLATION (VF) AND HIGH-RATE NON-SUSTAINED 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 23441892 ↗
• MalfunctionOct 27, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN-CLINIC AND NORMAL DEVICE FUNCTION WAS NOTED. THERE WERE NO CRT-D OR LEAD ISSUES IDENTIFIED AND THE PATIENT SYMPTOMS WERE NOT DEVICE RELATED.

  Patient problems: Dizziness; Fall; Headache

  MAUDE report 23389879 ↗
• MalfunctionAug 12, 2025Over-Sensing; Under-Sensing; Over-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: Arrhythmia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787322 ↗
• InjuryJul 23, 2025Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Appropriate Device Problem Term/Code Not Available; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE DEVICE WAS EMITTING AN ON/OFF TONE MULTIPLE TIMES A DAY. IT WAS SUSPECTED THAT THE CADENCE WAS DUE TO A POSSIBLE RIGHT VENTRICULAR (RV) LEAD ALERT. THE PATIENT WAS ADVISED TO CONTACT THEIR PHYSICIAN. 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 22577437 ↗
• MalfunctionJul 11, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE THAT WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND 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 22484360 ↗
• MalfunctionJun 18, 2025Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO DIZZINESS/NEAR SYNCOPE AND CONGESTIVE HEART FAILURE. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DECREASE IN R-WAVE AMPLITUDE NOTED ON LEAD TRENDS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Heart Failure/Congestive Heart Failure; Presyncope

  MAUDE report 22286558 ↗
• InjuryJun 13, 2025Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD APPEARS TO POTENTIALLY HAVE A SUSPECTED RV TIP ELECTRODE FRACTURE. IT WAS NOTED THAT THE RV LEAD TRIGGERED A BIPOLAR AND TIP TO COIL IMPEDANCE WARNING DUE TO HIGH AND UNDEFINED IMPEDANCE MEASUREMENT. 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 22205545 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION AND HEALING ISSUES THAT PRESENTED WITH DISCOMFORT, EROSION, PAIN, AND REDNESS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Impaired Healing; Pain; Unspecified Infection

  MAUDE report 22187034 ↗
• InjuryMay 21, 2025Fracture; Over-Sensing; Fracture; 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. DEVICE DETECTIONS/THERAPIES WERE PROGRAMMED OFF. 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 22061899 ↗
• InjuryMay 14, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS WHICH RESULTED IN PREMATURE BATTERY DEPLETION. 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 22022219 ↗
• InjuryApr 18, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS CONCERN WITH OVERSENSING FROM THE RIGHT VENTRICULAR (RV) LEAD. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPROGRAMMED, AND THE RV LEAD WAS NOT BEING UTILIZED TO PACE OR SENSE. THE RV LEAD REMAINS IN PLACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867732 ↗
• InjuryApr 17, 2025Over-Sensing; Low impedance; Over-Sensing; Low impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYNCOPE. A TRANSMISSION REPORT INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) LOW PACING IMPEDANCE, SEVERAL HIGH-RATE NON-SUSTAINED EPISODES AND WAS OVERSENSING DURING ARRHYTHMIA DETECTIONS. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 21857826 ↗
• MalfunctionApr 3, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD INAPPROPRIATELY WITHHELD THERAPY DURING EPISODES OF VENTRICULAR FIBRILLATION (VF) THAT WERE DETECTED AS A SUPRA VENTRICULAR TACHYCARDIA (SVT). IN ADDITION, THERE WAS POSSIBLE RIGHT VENTRICULAR OVER-SENSING FOLLOWING THE SHOCK, THAT DID NOT APPEAR TO AFFECT DEVICE FUNCTION. THE ICD AND RIGHT VENTRICULAR (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 21761755 ↗
• MalfunctionJan 6, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS OCCASIONAL UNDERSENSED BEATS ON THE RIGHT VENTRICULAR (RV) LEAD. 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 21080371 ↗