Sprint Quattro Secure S™ DXAC/DSP 693575 (UDI 00613994446114)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994446114), received between Aug 9, 2017 and Jul 10, 2023 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “High impedance” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2023Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Under-Sensing; Impedance Problem; High Capture Threshold; Unstable Capture Threshold; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Under-Sensing; Impedance Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS FURTHER REPORTED THAT PRIOR TO REPROGRAMMING NOISE WAS ABLE TO BE REPRODUCED WITH ARM MOVEMENTS.

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

  MAUDE report 17287841 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POCKET INFECTION WITH ENDOCARDITIS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT- D) SYSTEM WAS REMOVED. THE PATIENT WAS NOTED TO HAVE AN OCCLUDED/STENOSED SUPERIOR VENA CAVA (SVC). A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND ENDOVASCULAR MECHANICAL THROMBECTOMY WERE PERFORMED ALONG WITH STENT PLACEMENT, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Obstruction/Occlusion; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 15808142 ↗
• InjuryOct 12, 2021Fracture; Capturing Problem; Fracture; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A THRESHOLDS RISE AFTER A TRICUSPID VALVE REPLACEMENT PROCEDURE. THE LEAD WAS SUSPECTED TO HAVE BEEN FRACTURED. A NEW PACE/SENSE LEAD WAS IMPLANTED. THE HIGH VOLTAGE PORTION OF 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 12615214 ↗
• InjuryJun 7, 2021Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Capturing Problem; Impedance Problem; Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Low impedance; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY. THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND A HIGH NUMBER OF SHORT V-V INTERVALS. IN ADDITION, THE RV LEAD TRIGGERED ALERTS FOR OVERSENSING OF NOISE, HIGH PACING IMPEDANCE, AND LOW PACING IMPEDANCE. THE RV LEAD ALSO HAD AN ACUTE DECREASE IN PACING IMPEDANCE AND THRESHOLDS WERE ELEVATED. ALL VENTRICULAR FIBRILLATION (VF)/ VENTRICULAR TACHYCARDIA (VT) DETECTIONS WERE PROGRAMMED OFF. 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 11947944 ↗
• InjuryOct 19, 2020Break; Connection Problem; High Capture Threshold; Break; Connection Problem; High Capture Threshold

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR CHANGE HIGH THRESHOLDS WERE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE INSULATION AROUND THE RV PACE/SENSE ELECTRODE WAS "OUT OF PLACE" AND WAS UNABLE TO BE INSERTED INTO NEW DEVICE HEADER. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND A PREVIOUSLY CAPPED LEAD WAS UNCAPPED AND USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10697593 ↗
• InjuryAug 29, 2019High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH DEFIBRILLATION IMPEDANCE MEASUREMENT. 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 8946616 ↗
• MalfunctionOct 22, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH RV COIL IMPEDANCE. THE RV 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 7990011 ↗
• InjuryMay 11, 2018Fracture; High impedance; Over-Sensing; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS HEARING AUDIBLE TONES. AN INTERROGATION OF THE DEVICE WAS PERFORMED AND IT WAS FOUND THAT A LEAD INTEGRITY ALERT WAS TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO SIC (SENSING INTEGRITY COUNTER) AND HRNS (HIGH RATE NON-SUSTAINED) EPISODES. THERE WERE ALSO TWO ALERTS TRIGGERED FOR RV LEAD IMPEDANCE OUT OF RANGE FOR HIGH/UNDEFINED PACING IMPEDANCE. IT WAS ALSO NOTED THAT POTENTIAL OVERSENSING WAS OBSERVED ON STORED EGMS (ELECTROGRAMS). A POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE RV LEAD WAS EXPLANTED AND NOT REPLACED AS THE PATIENT RECEIVED A COMPETITOR SUB Q IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7508616 ↗
• MalfunctionAug 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD HAD A "PERFORMANCE ISSUE." FOLLOW-UP WAS ATTEMPTED, BUT NO FURTHER INFORMATION WAS OBTAINED. THE LEAD HAS BEEN EXTRACTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6782704 ↗