SPRINT QUATTRO SECURE S™ DXAC/DSP 693558 (UDI 00643169535909)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00643169535909), received between Feb 9, 2017 and Aug 11, 2026 — classified as 2 deaths, 14 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (9 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to a pocket infection. Additionally, the patient experienced swelling. A new ICD system was implanted two days later. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Swelling/ Edema

  MAUDE report 50201366 ↗
• MalfunctionApr 16, 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 24903927 ↗
• InjuryOct 11, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, ELEVATED SENSING INTEGRITY COUNTER (SIC), AND NOISE. 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 20431397 ↗
• DeathJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE PATIENT FURTHER SUFFERED A BRAIN BLEED. THE PATIENT IS DECEASED.

  Patient problems: Endocarditis

  MAUDE report 17300205 ↗
• InjuryJul 6, 2023Adverse 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. THE INFECTION WAS NOTED TO BE UNRELATED TO THE DEVICE SYSTEM; HOWEVER, THE SOURCE OF THE INFECTION WAS NOT PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17274215 ↗
• MalfunctionMay 30, 2023Under-Sensing; Decreased Sensitivity; High Capture Threshold; Under-Sensing; Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS UNDERSENSING CAUSING FALSE TERMINATION OF CLASSIFIED VENTRICULAR TACHYCARDIA NON-SUSTAINED (VT-NS) EPISODES. THE LEAD HAS HIGH THRESHOLDS AND CHRONICALLY LOW R-WAVE SENSING. 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 17019824 ↗
• DeathFeb 7, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT IS DECEASED AND QUESTIONED IF THE DEVICE WAS WORKING PROPERLY AS THE PATIENT HAD PASSED AWAY AND NO SHOCKS WERE REPORTED TO HAVE BEEN DELIVERED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CLINIC BUT WAS NOT AVAILABLE. THE CAUSE OF DEATH WAS OBTAINED AS: CONGESTIVE HEART FAILURE, ARTERIOSCLEROSIS, CARDIOMYOPATHY AND STAGE III CHRONIC KIDNEY DISEASE.

  Patient problems: Arteriosclerosis/ Atherosclerosis; Cardiomyopathy; Heart Failure/Congestive Heart Failure; Unspecified Kidney or Urinary Problem

  MAUDE report 16315464 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SEVEN YEARS AFTER IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE BACTEREMIA WAS SUSPECTED TO BE FROM THE PATIENT¿S DIALYSIS PORT. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 15969197 ↗
• InjuryFeb 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT THEIR WAS AN ALERT ON THE RIGHT VENTRICULAR (RV) LEAD FOR HIGH/UNDEFINED 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 13515409 ↗
• MalfunctionJan 24, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED BY HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO NOTED THAT THERE WAS OVERSENSING ON THE RV LEAD. 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 13333889 ↗
• MalfunctionNov 29, 2021Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FAILED TO CAPTURE AND HAD "PACING SPIKES". 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 12883699 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DVT WAS IDENTIFIED VIA BILATERAL LOWER EXTREMITY ULTRASOUND AS NON-OCCLUSIVE LEFT POPLITEAL DVT. THE PATIENT WAS STARTED ON ANTICOAGULATION THERAPY, HOWEVER IT WAS STOPPED DUE TO THE PATIENT HISTORY OF SEVERE EPITAXIES WHILE ON ANTICOAGULATION THERAPY. A INFERIOR VENA CAVA FILTER WAS PLACED WITHOUT COMPLICATION AND THE DVT WAS INDICATED AS RESOLVED. IT WAS ALSO REPORTED THAT THE DVT WAS NOT RELATED TO THE PRODUCT.

  Patient problems: Chills; Dyspnea; Fever; Unspecified Infection

  MAUDE report 11554918 ↗
• InjuryFeb 24, 2021Signal Artifact/Noise; High impedance; Over-Sensing; Impedance Problem; Signal Artifact/Noise; High impedance; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT AN ALERT WAS TRIGGERED. THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE HIGH/ UNDEFINED PACING IMPEDANCE. ADDITIONALLY, IT WAS NOTED THAT ALERTS HAD ALSO BEEN TRIGGERED FOR SHORT V-V INTERVALS, NON-SUSTAINED EPISODES, IMPEDANCE VARIATION AND NOISE. REPROGRAMMING WAS INDICATED TO HAVE BEEN PERFORMED. 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 11372411 ↗
• MalfunctionJan 21, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR LOW IMPEDANCE OUT OF RANGE ON THE RV COIL DURING A SURGICAL PROCEDURE. 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 9613289 ↗
• InjuryNov 6, 2019Over-Sensing; Over-Sensing

  THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 9285743 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED THE PATIENT DEVELOPED A POCKET INFECTION. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9205603 ↗
• MalfunctionJul 25, 2019Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PACING RATE WAS LOWER THAN THE PROGRAMMED LOW RATE. IT WAS SUSPECTED THAT THIS WAS DUE TO THE PATIENT'S HIGH POTASSIUM LEVELS CAUSING THE RIGHT VENTRICULAR (RV) LEAD TO EXHIBITED T-WAVE OVERSENSING (TWOS). THE PATIENT'S POTASSIUM LEVELS WERE BEING TREATED. THE CRT-D AND RV LEAD REMAIN IN USE AND WILL BE MONITORED AS THE PATIENT'S POTASSIUM LEVELS IMPROVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8827084 ↗
• InjuryAug 29, 2018Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL AND OVERSENSING OF NOISE WITH HIGH RATE NON-SUSTAINED (HR-NS), VENTRICULAR TACHYCARDIA NON-SUSTAINED (VT-NS), AND SENSING INTEGRITY COUNTER (SIC) EPISODES. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAS A HIGH INCREASING THRESHOLD THAT WAS GREATER THAN THE PROGRAMMED SAFETY MARGIN. THE LEAD REMAINS IN USE. THE PATIENT WILL FOLLOW UP WITH THE PHYSICIAN FOR FURTHER EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7825685 ↗
• InjuryJul 12, 2018Signal Artifact/Noise; Fracture; Over-Sensing; Device Displays Incorrect Message; Impedance Problem; Noise, Audible; Signal Artifact/Noise; Fracture; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) AS WELL AS A LEAD NOISE WARNING FOR OVERSENSING-NOISE EPISODES AND LEAD IMPEDANCE WARNINGS FOR RISING PACING IMPEDANCE. OVERSENSING WAS ALSO NOTED UPON MANIPULATION OF THE PATIENT¿S LEFT ARM. A FRACTURE OF THE RV LEAD WAS CONFIRMED. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7681881 ↗
• InjuryFeb 8, 2018Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  ABOUT THREE WEEKS POST IMPLANT, THAT THE RIGHT VENTRICULAR (RV) LEAD HAD PULLED BACK AND HAD NO CAPTURE AT FIVE VOLTS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254520 ↗
• MalfunctionOct 6, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD THE HELIX WOULD NOT EXTEND. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6923743 ↗
• InjuryAug 9, 2017Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH THRESHOLDS. THE RIGHT ATRIAL (RA) LEAD ALSO DISPLAYED HIGH THRESHOLDS ALONG WITH INTERMITTENT CAPTURE. BOTH RV AND RA LEAD HAVE BEEN EXTRACTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6782419 ↗
• MalfunctionJun 8, 2017Bent; Device Sensing Problem; Bent; Device Sensing Problem

  IT WAS REPORTED THAT DURING THE ATTEMPTED IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD, AFTER MULTIPLE EXTENSIONS AND RETRACTIONS OF THE HELIX BECAUSE OF POOR SENSING, THE LEAD WAS REMOVED FROM THE BODY AND EXAMINED. THE PHYSICIAN NOTED THAT THE TIP WAS ASKEW AND THE HELIX WAS PLUGGED WITH TISSUE. THE LEAD WAS NOT USED AND A DIFFERENT LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6626683 ↗
• MalfunctionApr 6, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND RISING IMPEDANCE. THE RV LEAD WAS CAPPED. DURING REPLACEMENT OF THE RV LEAD, THE HELIX OF THE REPLACEMENT LEAD WOULD NOT DEPLOY PROPERLY. A DIFFERENT REPLACEMENT LEAD WAS CHOSEN AND IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6468943 ↗
• MalfunctionFeb 9, 2017Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT FOUR DAYS POST IMPLANT, A RIGHT VENTRICULAR (RV) LEAD INTEGRITY WARNING WAS TRIGGERED FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. IT WAS DETERMINED THAT THE LEAD WAS EXHIBITING T-WAVE OVERSENSING (TWOS) . 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 6320650 ↗