Sprint Quattro Secure S® 6935M62 (UDI 00613994718853)Recalls & reported problems

Summary

The FDA's MAUDE database contains 735 adverse event reports that list this exact device (DI 00613994718853), received between Feb 9, 2017 and Sep 28, 2026 — classified as 11 deaths, 477 injuries, 247 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (290 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 735 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was removed due to systemic infection with vegetation noted on the Right Ventricular (RV) and Right Atrial (RA) leads. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50916086 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 50888810 ↗
• MalfunctionSep 4, 2026Decreased Sensitivity

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615586 ↗
• MalfunctionAug 27, 2026Impedance Problem

  It was reported that the Right Ventricular (RV) lead triggered an alert for out of range 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 50470716 ↗
• InjuryAug 26, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a waning for two or more High Rate-Non Sustained episodes and Sensing Integrity Counter (SIC).  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 50460697 ↗
• MalfunctionAug 20, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50348643 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) was visible from the incision area two months post-generator replacement procedure and the device pocket was infected with pus around the area. The ICD was removed and the Right Ventricular (RV) lead was capped. A new system was implanted on the patient's opposite side several days later. No further patient complications have been reported as a result of this event.

  Patient problems: Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 50175660 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a dual-chamber Implantable Cardioverter Defibrillator (ICD) patient experienced pocket erosion. The ICD system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Pocket Erosion

  MAUDE report 50101761 ↗
• InjuryJul 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that one day post implant of the Implantable Cardioverter Defibrillator (ICD) the patient had a stroke which damaged the patient's fontal lobe. The device was explanted and replaced approximately eleven years later. The Right Atrial (RA) lead and Right Ventricular (RV) lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Stroke/CVA

  MAUDE report 50037402 ↗
• MalfunctionJul 8, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR AT/AF WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF). THE DEVICE AND LEADS 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 25751662 ↗
• InjuryJul 7, 2026Signal Artifact/Noise; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WHICH RESULTED TO INAPPROPRIATE INHIBITION. THE PATIENT EXPERIENCED ASYSTOLE AND WAS STATED TO BE PACEMAKER DEPENDENT. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25739309 ↗
• MalfunctionJul 1, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING. THE RA AND RV 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 25682127 ↗
• InjuryJun 24, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE PATIENT IS BEING PACED BY THE RIGHT ATRIAL (RA) LEAD AND THE RV LEAD WAS NEVER USED TO PACE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613687 ↗
• MalfunctionJun 24, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY HEARD A BEEPING SOUND COMING FROM THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THAT OCCURRED EVERY FOUR HOURS, INCLUDING AT NIGHT. THE ALERT CADENCE WAS INDICATIVE OF AN RIGHT VENTRICULAR (RV) LEAD ISSUE. 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 25612207 ↗
• MalfunctionJun 22, 2026Over-Sensing

  IT WAS REPORTED THAT MYOPOTENTIALS WERE OBSERVED ON THE CURRENT ELECTROGRAMS (EGM). 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 25585134 ↗
• InjuryJun 11, 2026Fracture; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED OUT OF RANGE (OOR) HIGH DEFIBRILLATION AND PACING IMPEDANCE, RISING DEFIBRILLATION IMPEDANCE, HIGH THRESHOLD,  AND WAS SUSPECTED TO HAVE HIGH VOLTAGE FRACTURE.  THE LEAD WAS CUT, 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 25474439 ↗
• MalfunctionJun 2, 2026Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN OVER PACING AND MISCLASSIFICATION OF AN ELECTROGRAMS (EGM). THE RA LEAD ALSO EXHIBITED HIGH THRESHOLDS. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE CAPTURE THRESHOLD. THE RA LEAD AND RV 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 25361406 ↗
• MalfunctionMay 20, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND T-WAVE OVERSENSING (TWOS). 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 25232206 ↗
• InjuryMay 13, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO CONFIRMED HIGH VOLTAGE RV COIL FRACTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163742 ↗
• MalfunctionApr 28, 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 25018078 ↗
• MalfunctionApr 27, 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 25000882 ↗
• MalfunctionApr 16, 2026High impedance; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING. THE LEAD EXHIBITED UNDEFINED HIGH AND VARYING DEFIBRILLATION IMPEDANCE. IN ADDITION, VARYING TIP TO COIL PACING IMPEDANCE WAS NOTED. 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 24899034 ↗
• MalfunctionApr 3, 2026Over-Sensing; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO PACING IMPEDANCE VARIATION 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 24780987 ↗
• MalfunctionMar 31, 2026Over-Sensing; Positioning Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HEARD ALERT TONES EVERY FOUR HOURS. THE PATIENT PRESENTED FOR REVIEW AND A LEAD INTEGRITY ALERT (LIA) WAS OBSERVED FOR THE RIGHT VENTRICULAR (RV) LEAD WHICH TRIGGERED FOR ELEVATED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. RV LEAD OVERSENSING WAS OBSERVED. IT WAS NOTED THAT THE RV LEAD DID NOT APPEAR TO BE IN THE BEST POSITION. 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 24749729 ↗
• MalfunctionMar 23, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). 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 24663391 ↗