SPRINT QUATTRO SECURE S™ DXAC/DSP 693565 (UDI 00643169535916)Recalls & reported problems

Summary

The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00643169535916), received between Dec 9, 2016 and Feb 24, 2026 — classified as 35 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (23 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 54 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO A HOSPITAL AFTER A SYNCOPAL EPISODE AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING PACING IMPEDANCE VALUES AND ALSO HAD HISTORICAL ALERTS FOR LOW, OUT-OF-RANGE PACING IMPEDANCES. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 24430216 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD AND POCKET INFECTION. TEMPORARY LEADS WERE USED, THEN A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23851478 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE LEADS WERE EXPLANTED APPROXIMATELY THREE MONTHS LATER.

  Patient problems: Erythema; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 23586701 ↗
• MalfunctionOct 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT ONE DAY POST IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT PROCEDURE THAT AN ALERT TRIGGERED EVERY FOUR HOURS, INDICATIVE OF A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ISSUE. 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 23383148 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION AND TRICUSPID VALVE VEGETATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21160669 ↗
• MalfunctionDec 6, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH RV COIL DEFIBRILLATION IMPEDANCE. ADDITIONALLY, THE RV LEAD DISPLAYED VARIABLE RV COIL DEFIBRILLATION 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 20865276 ↗
• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH LEFT FOOT PAIN AND CELLULITIS. IT WAS FURTHER NOTED THAT THE PATIENT HAD AN INFECTION WITH PAIN AND A FEVER. THE ORGANISMS WERE IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS, ENTEROCOCCUS FAECALIS, BACTEREMIA, AND OSTEOMYELITIS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED A FEW DAYS LATER AND SMALL VEGETATIONS WERE OBSERVED ON THE MITRAL VALVE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Cellulitis; Fever; Pain; Unspecified Infection

  MAUDE report 20675348 ↗
• InjuryAug 8, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THE 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 19945625 ↗
• InjuryFeb 29, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND NON-PHYSIOLOGIC/SENSING INTEGRITY COUNTER (SIC). 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 18807673 ↗
• InjuryFeb 12, 2024Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED DUE TO T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY NOTED THAT PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18685921 ↗
• MalfunctionNov 20, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT INTERMITTENT UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD AND OVERSENSING WITH A POSSIBLE FRACTURE ON THE RIGHT ATRIAL (RA) LEAD. 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 18173069 ↗
• InjuryAug 18, 2023Signal Artifact/Noise; Fracture; Over-Sensing; Decreased Sensitivity; Signal Artifact/Noise; Fracture; Over-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). IN ADDITION, A LEAD WARNING TRIGGERED DUE TO NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. R-WAVE AMPLITUDE LEVELS HAD DROPPED. 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 17572021 ↗
• InjuryJul 18, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; 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. IN ADDITION, NOISE WAS OBSERVED AND COULD BE REPRODUCED DURING IN PERSON LEFT ARM MOVEMENTS. 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 17342344 ↗
• MalfunctionMay 5, 2023Over-Sensing; Under-Sensing; Decreased Sensitivity; Over-Sensing; Under-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND OVERSENSED ONE VENTRICULAR BEAT. IN ADDITION, THERE WAS INTERMITTENT VENTRICULAR UNDERSENSING ON SOME STORED ELECTROGRAMS (EGM) AND A NOTED DECREASE IN R-WAVE MEASUREMENT ON LEAD TRENDS. 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 16874086 ↗
• InjuryMar 20, 2023Signal Artifact/Noise; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RV LEAD HAD EXHIBITED A SUSPECTED FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16571470 ↗
• MalfunctionDec 15, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS UNDERSENSING SEEN ON TREATED VENTRICULAR FIBRILLATION (VF) 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 15993200 ↗
• MalfunctionDec 15, 2022Capturing Problem; Impedance Problem; High Capture Threshold; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS FURTHER NOTED THAT IT WAS SUSPECTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PARASITIC CROSSTALK. THE DEVICE AND 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 15990635 ↗
• MalfunctionDec 8, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS INTERMITTENT OVERSENSING SEEN ON HIGH-RATE 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 15939426 ↗
• InjuryOct 13, 2022Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A PACING IMPEDANCE OUT OF RANGE ALERT. THE LEAD IMPEDANCE HAD BEEN INCREASING. 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 15600813 ↗
• MalfunctionSep 27, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). IN ADDITION, VENTRICULAR OVERSENSING WAS NOTED ON STORED ELECTROGRAMS (EGM). 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 15493389 ↗
• InjuryMay 3, 2022Fracture; High impedance; Over-Sensing; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE, HAD A POSSIBLE FRACTURE, SEVERAL HIGH RATE NON -SUSTAINED EPISODES, AND HAD A HIGH NUMBER OF SHORT V-V INTERVALS. THE LEAD WAS PROGRAMMED OFF AND SUBSEQUENTLY 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 14269479 ↗
• InjuryApr 14, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR PACE. 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 14112125 ↗
• InjuryOct 15, 2021Fracture; Capturing Problem; Impedance Problem; High Capture Threshold; Fracture; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH AND INCREASING THRESHOLDS AND INCREASING PACING IMPEDANCE. A POSSIBLE FRACTURE WAS SUSPECTED. 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 12639875 ↗
• InjuryDec 15, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). IT WAS NOTED THAT PATIENT WAS ASYMPTOMATIC WITH THE TWOS AND REPROGRAMMING WAS COMPLETED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. 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 11012373 ↗
• InjuryNov 4, 2020Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO A FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD HAD OVERSENSING WITH NOISE AND HIGH AND UNDEFINED PACING IMPEDANCE MEASUREMENTS. REPROGRAMMING WAS DONE AND THE RV LEAD SUBSEQUENT HAD HIGH AND UNDEFINED DEFIBRILLATION IMPEDANCE AND A LOSS OF CAPTURE. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD A POSSIBLE FRACTURE BECAUSE IT WAS NOT CAPTURING, AND THE IMPEDANCE MEASUREMENTS WERE HIGH. THERE WAS ALSO INDICATION OF VARIABLE CAPTURE AND HIGH AND LOW IMPEDANCE. DURING THE EXTRACTION PROCEDURE, ONCE THE RV LEAD WAS REMOVED, THE LV LEAD WAS TESTED THROUGH AN ANALYZER AND NOISE AND NO CAPTURE NOTED WITH VARIABLE IMPEDANCE MEASUREMENTS. BOTH THE RV LEAD AND LV LEAD WERE 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 10786939 ↗