Sprint Quattro MRI SureScanRecalls & reported problems across all models

We found 2 models of Sprint Quattro MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 175 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2018 and Sep 11, 2026 — classified as 3 deaths, 91 injuries, 81 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (63 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Sprint Quattro MRI SureScan problems

Sprint Quattro MRI SureScan models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sprint Quattro™ MRI SureScan™ 6946M62

  Implantable cardioverter defibrillator (non-CRT)
  1 death133 reports
• Sprint Quattro™ MRI SureScan™ 6946M55

  Permanent defibrillator electrodes
  2 deaths42 reports

Recent Sprint Quattro MRI SureScan adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 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 ↗
• 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 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 ↗
• 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 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 ↗
• 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 ↗

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