Sprint Quattro® 6946M62Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00643169335578), received between Dec 9, 2016 and Feb 16, 2026 — classified as 1 death, 17 injuries, 26 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED 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 24345784 ↗
• InjuryJan 27, 2026Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH PALPITATIONS. UPON REVIEW, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO INCREASED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. IN ADDITION, THE RV LEAD EXHIBITED OVERSENSING AND NOISE. THE RV LEAD ALSO TRIGGERED AN ALERT FOR UNDEFINED HIGH PACING IMPEDANCES. LOSS OF CAPTURE WAS ALSO NOTED ON THE RV LEAD AND THE RV AMPLITUDE WAS SET TOO HIGH. THE HIGH VOLTAGE THERAPY WAS REPROGRAMMED; VENTRICULAR FIBRILLATION (VF) DETECTION WAS PROGRAMMED OFF. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 24189515 ↗
• MalfunctionAug 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE WAS EMITTING AN ALERT TONE MULTIPLE TIMES A DAY. THE CADENCE OF THE ALERT WAS SUGGESTIVE OF A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT. 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 22833458 ↗
• MalfunctionMay 17, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT HAD TACHYCARDIA WITH A HEART RATE OF 140 BPM. THE NURSE REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT CAPTURING. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 19345044 ↗
• MalfunctionJan 24, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH NUMBER OF SENSING INTEGRITY COUNTERS (SIC). 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 18572173 ↗
• MalfunctionNov 9, 2023Failure to Capture; Capturing Problem; High Capture Threshold; Unstable Capture Threshold; Failure to Capture; Capturing Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, VARYING AND INCREASING THRESHOLDS. IT WAS ALSO NOTED THAT THE RV LEAD CAPTURE COULD NOT BE CONFIRMED. 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 18103745 ↗
• InjuryAug 29, 2023Adverse 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. APPROXIMATELY 2 WEEKS LATER, A REPLACEMENT SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17644150 ↗
• InjuryJun 30, 2023Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSING CAUSING INAPPROPATE SHOCKS. REPROGRAMMING OCCURRED AND THE LEAD WAS LATER CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17238177 ↗
• InjuryApr 7, 2023Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16700468 ↗
• MalfunctionFeb 15, 2023Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS DIMINISHED R-WAVE SENSING. THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS UNDERSENSING. 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 16378727 ↗
• MalfunctionNov 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A "WIRE ISSUE" AND SHORTNESS OF BREATH. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dysphasia; Dyspnea

  MAUDE report 15708040 ↗
• MalfunctionAug 29, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT UNDERSENSING WAS NOTED ON THE ATRIAL AND VENTRICULAR CHANNELS. THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD 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 15312085 ↗
• MalfunctionAug 18, 2022Device Sensing Problem; Unstable Capture Threshold; Device Sensing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNSTABLE CAPTURE AND SENSING 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 15249376 ↗
• MalfunctionAug 11, 2022Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT CHRONICALLY LOW R WAVES WERE NOTED 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 15213017 ↗
• MalfunctionJun 24, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THAT THE DEVICE HAS SHOWN ATRIAL UNDERSENSING. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD CONTINUED TO EXHIBIT UNDERSENSING WHICH RESULTED IN INAPPROPRIATE ATRIAL LEAD PACING AND INAPPROPRIATE RIGHT VENTRICULAR (RV) LEAD PACING. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH CAPTURE MARGIN AND IT WAS NOT PACING ENOUGH. THE LEADS REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14802663 ↗
• MalfunctionMar 25, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD INTERMITTENT UNDERSENSING. 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 13904300 ↗
• MalfunctionFeb 23, 2022High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND CHRONICALLY HIGH IMPEDANCE. IT WAS ALSO NOTED THAT THE RA LEAD WAS UNDERSENSING. NO ACTION WAS TAKEN AND 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 13585425 ↗
• MalfunctionApr 23, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS HIGH RATE NON-SUSTAINED EPISODES AND APPEARS TO BE OVERSENSING SEEN ON STORED ELECTROGRAMS (EGMS). 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 11717074 ↗
• MalfunctionMar 23, 2021Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH R-WAVES. 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 11552938 ↗
• InjuryDec 15, 2020Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY ROOM AFTER HEARING AN ALERT. THE SUPERIOR VENA CAVA (SVC) COIL ON THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH IMPEDANCE. REPROGRAMMING WAS PERFORMED TO TURN THE SVC COIL OFF. THREE DAYS LATER, AN ALERT WAS TRIGGERED FOR HIGH RV COIL IMPEDANCE. A POSSIBLE LEAD FRACTURE WAS SUSPECTED. THE SVC COIL WAS PROGRAMMED ON AGAIN BUT ALERTS WERE TURNED OFF. 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 11012081 ↗
• MalfunctionOct 8, 2020Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD CHRONICALLY LOW R WAVES. 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 10649899 ↗
• MalfunctionJul 8, 2020Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE PATIENT'S HISTORY OF HEART FAILURE EXACERBATION, ACUTE DECOMPENSATED HEART FAILURE (ADHF), AND AN INABILITY TO TAKE PRESCRIBED MEDICATIONS WAS THE REASON THE PATIENT HAS EXPERIENCED DYSPNEA. THERE WERE SEVERAL MEDICATION ADJUSTMENTS.

  Patient problems: Dyspnea

  MAUDE report 10245948 ↗
• InjuryJun 18, 2020Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE RIGHT VENTRICULAR (RV) LEAD FOR OVERSENSING OF NOISE, ARTIFACTS, AND T-WAVE. A FOLLOW UP WITH THE PATIENT¿S HEALTHCARE PROVIDER YIELDED THAT THE PATIENT WAS SEEN AND THE LEAD WAS ASSESS. THE LEAD CONTINUES TO BE MONITORED AND 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 10166285 ↗
• InjuryMay 7, 2020Adverse 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 POCKET INFECTION. THE PATIENT RECEIVED A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10031905 ↗
• MalfunctionFeb 5, 2020Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONICALLY LOW R-WAVES. 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 9671319 ↗