SPRINT QUATTRO SECURE® DXAC/DSP 694758 (UDI 00643169535961)Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00643169535961), received between Apr 6, 2017 and Feb 27, 2026 — classified as 17 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (12 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 27, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING THAT RESULTED IN T-WAVE OVERSENSING (TWOS). THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. IT WAS ALSO NOTED THAT PHRENIC NERVE STIMULATION WAS OBSERVED WITH THE LEFT VENTRICULAR (LV) LEAD. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 24472549 ↗
• MalfunctionFeb 19, 2025Under-Sensing; Low impedance; Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN OUT OF RANGE (OOR) FOR LOW 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 21410867 ↗
• MalfunctionMar 28, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW BUT STABLE 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 18996170 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEVICE SYSTEM WAS EXPLANTED DUE TO INFECTION. VEGETATION WAS ALSO OBSERVED. THE PATIENT EXPERIENCED DISCOMFORT, PAIN, AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 18780022 ↗
• InjuryNov 17, 2023Signal Artifact/Noise; Fracture; High impedance; Difficult to Remove; Impedance Problem; Signal Artifact/Noise; Fracture; High impedance; Difficult to Remove; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH AND RISING PACING IMPEDANCE. A LOW VOLTAGE FRACTURE WAS SUSPECTED, AND THE LEAD WAS PARTIALLY EXPLANTED. THERE WERE DIFFICULTIES WITH EXTRACTING THE LEAD DUE TO CALCIFICATION/TISSUE GROWTH PROXIMAL TO THE RV COIL CAUSING THE PHYSICIAN TO ABANDON EXTRACTING THE REMAINDER OF THE LEAD. THE LEAD REMAINS PARTIALLY IMPLANTED AND WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18159727 ↗
• MalfunctionJul 26, 2023Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS UNDERSENSING OBSERSERVED ON THE RIGHT VENTRICULAR (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 17396186 ↗
• InjurySep 19, 2022Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD LOW IMPEDANCE AND THE RIGHT VENTRICULAR (RV) LEAD HAD FRACTURED. THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 15445661 ↗
• InjuryJul 14, 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 REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15012304 ↗
• MalfunctionJun 7, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD MAY HAVE OCCASIONALLY UNDERSENSED A VENTRICULAR BEAT AS NOTED ON THE 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 14621618 ↗
• InjuryApr 25, 2022Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD HEARD AUDIBLE ALERTS FROM THEIR DEVICE, AND RECEIVED INAPPROPRIATE SHOCKS DUE TO FAILURE OF THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). IN ADDITION, THERE WAS INTERMITTENT HIGH PACING IMPEDANCE AND NOISE NOTED ON THE RV LEAD, AND OCCASIONAL NOISE NOTED ON THE ATRIAL CHANNEL. THE RV LEAD WAS PROGRAMMED OFF, AND THE PATIENT EXPERIENCED DYSPNEA. SUBSEQUENTLY, THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND REPLACED. THE RIGHT ATRIAL (RA) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Shock from Patient Lead(s)

  MAUDE report 14197800 ↗
• MalfunctionFeb 28, 2022Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). THERE WAS POSSIBLE OVERSENSING OBSERVED ON STORED ELECTROGRAMS. 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 13620808 ↗
• MalfunctionMar 22, 2021Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR LOW 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 11543461 ↗
• InjuryFeb 12, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGEOUT, THE PHYSICIAN ENCOUNTERED DIFFICULTY IN EXTRACTING THE RIGHT VENTRICULAR (RV) LEAD FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PORT, EVEN AFTER UTILIZING MULTIPLE ROTATION WRENCHES. AFTER MULTIPLE ATTEMPTS, THE LEAD INSULATION WAS STRIPPED AWAY FROM THE LEAD, AND THE LEAD FRACTURED. THE LEAD WAS EVENTUALLY DISCONNECTED, AND WAS SUBSEQUENTLY CAPPED AND REPLACED. THE PATIENT WAS NOTED TO HAVE EXPERIENCED ASYSTOLE DURING THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 11324593 ↗
• MalfunctionJan 7, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT WHILE THE PATIENT WAS IN THE HOSPITAL, A REMOTE MONITORING TRANSMISSION WAS SENT. THE REVIEW INDICATED THAT ONE EPISODE OF NON-SUSTAINED VENTRICULAR TACHYCARDIA HAD ONE UNDERSENSED BEAT. 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 11131198 ↗
• InjuryDec 9, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCES. 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 10978999 ↗
• MalfunctionNov 17, 2020Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT A LEAD IMPEDANCE WARNING OCCURRED. 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 10855770 ↗
• MalfunctionSep 29, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR LOW PACING LEAD IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10600597 ↗
• InjuryFeb 5, 2020Intermittent Capture; High impedance; High Capture Threshold; Intermittent Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, INTERMITTENT CAPTURE, AND HIGH PACING IMPEDANCE. THE RV LEAD WAS CAPPED AND NEW RV LEAD IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9673668 ↗
• InjuryDec 5, 2019Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing; Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OVERSENSING OF NOISE, SHORT VENTRICULAR INTERVALS, HIGH UNDEFINED PACING IMPEDANCE, AND NON-CAPTURE. THE LEAD WAS REPORTED TO HAVE FRACTURED. THE PATIENT REPORTEDLY EXPERIENCED SYNCOPAL EPISODES. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY HAD DEPLETED PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope

  MAUDE report 9415996 ↗
• InjuryNov 19, 2018Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; High Capture Threshold; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Impedance Problem; High Capture Threshold

  CORRECTION: IT WAS ALSO REPORTED THAT THE LEAD WAS POSSIBLY FRACTURED.

  Patient problems: No Known Impact Or Consequence To Patient; Shock from Patient Lead(s)

  MAUDE report 8083926 ↗
• InjuryOct 10, 2018Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO OVERSENSING. DURING THE REVISION PROCEDURE, WHEN THE RV LEAD WAS DISCONNECTED FROM THE DEVICE AND THE RV PORT WAS OPEN WITH THE DEVICE OUT OF THE POCKET SITTING ON THE PATIENT, PACING INHIBITION WAS NOTED WHEN THE PHYSICIAN TOUCHED THE CAN. THE RV 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 7953525 ↗
• InjuryJun 1, 2018Signal Artifact/Noise; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) WITH INCREASED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. ADDITIONALLY AN ALERT FOR RV LEAD NOISE WAS ALSO INDICATED. AN INTERVENTION WAS COMPLETED AND THE LOW-VOLTAGE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED AND NEW LOW-VOLTAGE PACE/SENSE LEAD WAS IMPLANTED, WHILE THE HIGH-VOLTAGE PORTION OF THE ORIGINAL 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; Shock from Patient Lead(s)

  MAUDE report 7560419 ↗
• InjuryApr 10, 2018Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE HAD PREVIOUSLY JUMPED. THE LEAD INTEGRITY ALERT (LIA) HAD NOW TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND PACING IMPEDANCE VARIATION. THE LEAD WAS REPROGRAMMED. 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 7418900 ↗
• MalfunctionApr 10, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ED (EMERGENCY DEPARTMENT) WITH CHEST PAIN. AN INTERROGATION OF THERE DEVICE WAS DONE AND IT WAS FOUND THAT AND ALERT FOR HIGH RV THRESHOLD WAS TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD HAS CHRONICALLY MEASURED HIGH FOR RV THRESHOLDS. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 7415416 ↗
• InjuryDec 7, 2017Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) WITH A ONE TIME IMPEDANCE SPIKE, HIGH RATE NON-SUSTAINED EPISODES, AND T-WAVE OVERSENSING (TWOS). FOLLOW-UP WITH AN ALLIED HEALTH PROFESSIONAL (AHP) AT THE PATIENT'S CLINIC REVEALED REPROGRAMMING HAD BEEN COMPLETED. 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 7092878 ↗