Sprint Quattro Secure® 6947M72 (UDI 00643169309739)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169309739), received between Apr 6, 2017 and Jul 2, 2026 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Impedance Problem

  IT WAS REPORTED THAT AN ALERT TRIGGERED FOR OUT OF RANGE PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN US E. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25693186 ↗
• MalfunctionAug 22, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT A LEAD WARNING TRIGGERED DUE TO OUT OF RANGE, HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. IT WAS FURTHER NOTED THAT THERE WAS ALSO A GRADUAL RISE IN RIGHT VENTRICULAR (RV) DEFIBRILLATOR, AND SVC COIL IMPEDANCE MEASUREMENTS, AND THAT THE PATIENT RECENTLY EXPERIENCED A FALL. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall

  MAUDE report 22876324 ↗
• MalfunctionJul 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE LEAD WAS EXPLANTED AFTER THE PATIENT EXPIRED IN A MANNER UNRELATED TO THE IMPLANTED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394295 ↗
• InjuryJan 29, 2025Signal Artifact/Noise; Capturing Problem; High Capture Threshold; Signal Artifact/Noise; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH RV THRESHOLDS AS WELL AS NOISE. IN ADDITION, IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED RISING AND HIGH ATRIAL THRESHOLDS AS WELL AS NOISE. THE RV LEAD AND RA LEAD WERE REPROGRAMMED AND LATER BOTH 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 21267423 ↗
• InjuryDec 9, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE ON THE PACING PORTION OF THE LEAD AS WELL AS ON BOTH DEFIBRILLATION COILS. 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 20879289 ↗
• InjuryNov 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A LOW VOLTAGE FRACTURE. 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 20708067 ↗
• InjurySep 13, 2023Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO A CONFIRMED LOW VOLTAGE FRACTURE. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED HIGH PACING IMPEDANCE AND A SPIKE IN PACING IMPEDANCE. THE PATIENT WAS HOSPITALIZED AND THE RV LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17740007 ↗
• MalfunctionAug 9, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ,TRIGGERED A LEAD, INTEGRITY ALERT (LIA) DUE TO A HIGH SENSING INTEGRITY COUNTER (SIC) VALUE 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 17490781 ↗
• MalfunctionDec 13, 2022Impedance Problem; High Capture Threshold; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWED A STEADY INCREASE IN PACING IMPEDANCE AND RV TIP TO COIL IMPEDANCE. IN ADDITION, THE LEAD ALSO DISPLAYED 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 15970509 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. A REPLACEMENT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14734926 ↗
• MalfunctionMar 9, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 11446085 ↗
• InjurySep 17, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE HIGH VOLTAGE PORTIONS OF THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547633 ↗
• InjuryAug 20, 2020Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND THERE WAS A RISE IN THE RIGHT VENTRICULAR (RV) LEAD THRESHOLDS AND IMPEDANCE VALUES OVER THE PAST FOUR MONTHS. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 10434202 ↗
• MalfunctionSep 6, 2019Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PACING BELOW THE LOWER RATE. THE ICD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8970191 ↗
• InjuryJul 30, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR OVERSENSING WITH HIGH RATE NON-SUSTAINED (HR-NS) AND SENSING INTEGRITY COUNTER (SIC) EPISODES. THE PATIENT WAS NOTED TO HAVE HYDRATION ISSUES DURING THE HOT SUMMER. THE RV LEAD WAS FOUND TO HAVE T-WAVE OVERSENSING (TWOS) CAUSING FALSE POSITIVE LIA. THE LEAD WAS REPROGRAMMED AND CONTINUES TO BE MONITORED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8843058 ↗
• InjuryJan 30, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING T WAVES. REPROGRAMMING OPTIONS WERE DISCUSSED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288762 ↗
• InjuryApr 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO THE PATIENT'S WOUND "NOT CLOSING". IT WAS ALSO REPORTED THAT THE SURGEON NOTED THE POCKET DID NOT APPEAR TO BE INFECTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Impaired Healing

  MAUDE report 6470003 ↗