Sprint Quattro® 6946M55Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169335561), received between Feb 9, 2017 and May 19, 2025 — classified as 1 death, 10 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025High impedance; Impedance Problem; High Capture Threshold; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD. IT WAS ALSO REPORTED THAT THE LEAD TRIGGERED AN ALERT DUE TO HIGH OUT OF RANGE (OOR) PACING IMPEDANCE. IT WAS NOTED THAT THE PACING IMPEDANCE MEASUREMENTS ARE RISING. 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 22047142 ↗
• InjuryJul 24, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS DUE TO HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE AND UNDEFINED HIGH OOR SUPERIOR VENA CAVA (SVC) IMPEDANCE. IT WAS NOTED THAT THE RV LEAD EXHIBITED VARIABLE PACING, DEFIBRILLATION, AND SVC IMPEDANCE TRENDS. 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 19822361 ↗
• DeathApr 5, 2024Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE LEAD ALSO EXHIBITED NOISE AND FURTHER EPISODES OF SHORT VENTRICLE TO VENTRICLE INTERVALS. THE PHYSICIAN WILL CONTINUE TO MONITOR THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19054005 ↗
• MalfunctionJan 13, 2023Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD BEGAN EXHIBITING A GRADUAL INCREASE IN PACING IMPEDANCE THAT HAS SINCE PLATEAUED. IT WAS ALSO NOTED THAT THIS INCREASE COINCIDED WITH A SMALL INCREASE IN RV THRESHOLDS AS WELL. 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 16157145 ↗
• InjuryOct 28, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT STORED ELECTROGRAMS ON A REMOTE TRANSMISSION SHOWED POSSIBLE INTERMITTENT T-WAVE OVERSENSING (TWOS) 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 12711180 ↗
• InjuryMay 3, 2021Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS FURTHER REPORTED THAT THE LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760523 ↗
• MalfunctionJun 18, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT WAS AT THE HOSPITAL AND A DEVICE CHECK WAS DONE. INFORMATION RECEIVED ON THE REMOTE TRANSMISSION WAS REVIEWED BY QUALIFIED PERSONNEL. IT WAS FOUND THAT THERE IS POSSIBLE T-WAVE OVERSENSING (TWOS) OBSERVED ON STORED EGMS (ELECTROGRAMS) FOR THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONALLY, THE DEVICE DELIVERED SUSPECTED ATP (ANTI-TACHYCARDIA PACING) FOR POSSIBLE RVR (RAPID VENTRICULAR RESPONSE) AS AN ATRIAL ARRHYTHMIA WAS IN PROGRESS AT TIME OF THERAPY. THE COMPANY FIELD REPRESENTATIVE WAS NOTIFIED AND CONTACTED THE PHYSICIAN. THE PHYSICIAN REQUESTED NO FOLLOW-UP FROM THE ON-CALL COMPANY FIELD REPRESENTATIVE. THE RV LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10168114 ↗
• InjuryJun 15, 2020High impedance; Over-Sensing; Impedance Problem; High impedance; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO IMPEDANCE VARIATION AND SIC (SENSING INTEGRITY COUNTER). AN ALERT FOR PACING IMPEDANCE WAS ALSO TRIGGERED DUE TO HIGH AND UNDEFINED PACING IMPEDANCES ON THE LEAD. THERE WAS ALSO ONE HIGH RATE NON-SUSTAINED EPISODES NOTED THAT SHOWED OVERSENSING. IT WAS NOTED THAT THE PATIENT WAS DOING PUSH UPS AT THE TIME OF THE ALERT. THE RV LEAD WAS REVISED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153191 ↗
• MalfunctionDec 4, 2018Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) WHILE THE PATIENT WAS OUT WALKING. MULTIPLE T-WAVE OVERSENSING (TWOS) EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC) WERE NOTED. THE TWOS WAS NOT REPRODUCIBLE. 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 8131034 ↗
• InjuryNov 12, 2018Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT HAD A TWITCHING/TICKING SENSATION UNDER THEIR LEFT BREAST. AN INTERROGATION INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH THRESHOLD. REPROGRAMMING WAS PERFORMED TO REDUCE THE THRESHOLD. THE PATIENT IS A PARTICIPANT IN THE ADAPTRESPONSE STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 8061301 ↗
• MalfunctionNov 1, 2018Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED FOR THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD EXHIBITED OVERSENSING, UNDERSENSING, ELEVATED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. 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 8028352 ↗
• MalfunctionAug 2, 2018High impedance; Decreased Sensitivity; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR HIGH IMPEDANCE. THE LEAD ALSO EXHIBITED A SLIGHT SENSING DECREASE FROM HISTORICAL MEASUREMENTS. CURRENT IMPEDANCE AND SENSING ARE STABLE. 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 7743000 ↗
• InjuryJul 18, 2018Fracture; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Fracture

  IT WAS FURTHER CLARIFIED THAT SINCE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND REMAINS IN THE PATIENT.

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

  MAUDE report 7700800 ↗
• InjuryApr 10, 2018Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Sensing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DAY FOLLOWING IMPLANT THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO BE DISLODGED. IT WAS NOTED THERE WAS A R-WAVE CHANGE AND THRESHOLD CHANGE. THE LEAD WAS REVISED WITHOUT COMPLICATION AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Tachycardia

  MAUDE report 7418905 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION "NOT AT THE DEVICE SITE" AND VEGETATION WAS NOTICED ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RV LEAD WERE EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7254863 ↗
• MalfunctionDec 7, 2017Break; Break

  IT WAS REPORTED THAT A LEAD WAS ATTEMPTED BUT NOT USED DURING AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE PROXIMAL PORTION OF THE LEAD LOOKED DAMAGED. A DIFFERENT LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7093748 ↗
• InjuryOct 6, 2017Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (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 Known Impact Or Consequence To Patient

  MAUDE report 6923761 ↗
• MalfunctionAug 9, 2017Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT AT THE END OF THE CASE, DURING POCKET CLOSURE, THERE WERE SEVERAL RECORDED OS (OVERSENSING) EVENTS THAT OCCURRED OF A BRIEF PERIOD. THE OVERSENSING SELF-TERMINATED AND WAS NOT SEEN SINCE. IT WAS NOTED THAT ALL MEASUREMENTS OF THE RIGHT VENTRICULAR (RV) LEAD ARE CURRENTLY STABLE. THE PHYSICIAN IS COMFORTABLE WITH THE CURRENT STATUS AND 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 6781454 ↗
• MalfunctionFeb 9, 2017High impedance; Mechanical Problem; High impedance; Mechanical Problem

  IT WAS REPORTED THAT DURING AN INITIAL IMPLANT PROCEDURE, A RIGHT VENTRICULAR (RV) LEAD WAS POSITIONED, TESTED, AND SECURED TO THE I MPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). TESTING THROUGH THE DEVICE REVEALED HIGH PACING IMPEDANCE. THE LEAD WAS REMOVED FROM THE CONNECTOR BLOCK, REPOSITIONED, AND WOULD NOT GO THROUGH THE CONNECTOR BLOCK. THE DEVICE SET SCREW WAS BACKED OUT AND REATTEMPTED BUT THE LEAD WOULD STILL NOT GO THROUGH THE CONNECTOR BLOCK. THE ICD WAS REMOVED AND A NEW DEVICE WAS CONNECTED WITH THE SAME RESULTS, SO THE PHYSICIAN DECIDED TO IMPLANT A NEW RV LEAD. THE NEW LEAD WENT THROUGH THE CONNECTOR BLOCK WITH NO ISSUES AND WAS ULTIMATELY POSITIONED, TESTED, AND IMPLANTED WITHOUT INCIDENCE. IT WAS FELT THAT THERE WAS A CONNECTOR PIN ISSUE WITH THE ORIGINAL LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6320114 ↗