SPRINT QUATTRO SECURE® DXAC/DSP 694765 (UDI 00643169535947)Recalls & reported problems
Medtronic, Inc. · LEAD 694765 SPRINT QUATTRO US SI MCRD · Class 3 · Implant
All models of Medtronic Sprint Quattro Lead (67) · SPRINT QUATTRO SECURE DXAC/DSP (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic Sprint Quattro Secure implantable defibrillator lead, the wire that sits in the heart and delivers pacing and shock therapy. Most of the 37 reports describe the lead giving alerts or behaving oddly — picking up noise or extra signals it shouldn't, showing odd electrical readings, or developing a suspected small crack — and in several cases the lead was taken out and replaced. There were 26 injuries and 11 malfunctions reported, with no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00643169535947), received between Apr 6, 2017 and Sep 11, 2026 — classified as 26 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (15 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.
Reports received per month
Most reported problems
Device problems
- Over-Sensing15
- High impedance11
- Fracture10
- High Capture Threshold5
- Impedance Problem5
- Device Dislodged or Dislocated4
- Adverse Event Without Identified Device or Use Problem3
- Low impedance3
Patient problems
- No Known Impact Or Consequence To Patient16
- No Clinical Signs, Symptoms or Conditions15
- Shock from Patient Lead(s)3
- Unspecified Infection3
- Endocarditis1
- Fungal Infection1
- Sepsis1
- Ventricular Fibrillation1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Signal Artifact/Noise
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734045 ↗MalfunctionMar 19, 2025High impedance; High impedance
IT WAS REPORTED THAT THE PATIENT HEARD AN ALERT EVERY FOUR HOURS, WHICH IS THE CADENCE INDICATIVE OF A LEAD INTEGRITY ALERT (LIA). A REMOTE MONITORING TRANSMISSION SHOWED THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH SUPERIOR VENA CAVA (SVC) LEAD 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 21644127 ↗MalfunctionMar 11, 2025Low impedance; Low impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RV LEAD IMPEDANCE WAS CHRONICALLY LOW AND THE TREND REMAINED UNCHANGED. NO INTERVENTION WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21570985 ↗InjuryJan 15, 2025Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem
IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED FOR SENSING INTEGRITY COUNTER (SIC) AND IMPEDANCE VARIATION. 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 21161629 ↗MalfunctionOct 4, 2024Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND T-WAVE OVERSENSING (TWOS) WAS NOTED POST THERAPY ON A STORED EPISODE. 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 20369934 ↗MalfunctionAug 13, 2024Low impedance; Low impedance
IT WAS REPORTED THAT THE PATIENT HEARD AN AUDIBLE ALERT. CLINICAL DATA FROM THE IMPLANTED DEVICE SYSTEM WAS REVIEWED BY QUALIFIED PERSONNEL AND INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR OUT OF RANGE (OOR) 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 19977931 ↗MalfunctionJul 11, 2024Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem
IT WAS REPORTED THAT A LEAD IMPEDANCE WARNING TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD. THERE HAS BEEN A GRADUAL INCREASE IN PACING IMPEDANCE, FOLLOWED BY A GRADUAL INCREASE IN CAPTURE THRESHOLDS. 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 19720870 ↗InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT PRESENT TO THE ELECTROPHYSIOLOGY (EP) LAB FOR EXTRACTION DUE TO INFECTION. THE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 19529378 ↗InjuryFeb 26, 2024Signal Artifact/Noise; Fracture; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Fracture; Over-Sensing; Impedance Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) AND EXHIBITED NOISE, OVERSENSING, AND SPIKE IN PACING IMPEDANCE. A LOW VOLTAGE FRACTURE WAS SUSPECTED. DETECTIONS AND ALL ALERTS WERE PROGRAMMED OFF, AND THE RV LEAD WAS 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 18778721 ↗InjuryJan 26, 2024Fracture; Fracture
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO A SUSPECTED FRACTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18589686 ↗InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD A FUNGAL BLADDER INFECTION AND BECAME SEPTIC. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS DONE THAT REVEALED VEGETATION ON THE RIGHT VENTRICULAR (RV) LEADS AND ENDOCARDITIS. THE ICD WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Endocarditis; Fungal Infection; Sepsis; Unspecified Infection
MAUDE report 17258591 ↗MalfunctionJul 3, 2023Decreased Sensitivity; Decreased Sensitivity
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DECREASE IN R WAVES OVER THE PAST YEAR. BOTH 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 17248092 ↗InjuryApr 19, 2023Intermittent Capture; Failure to Capture; High impedance; Over-Sensing; Capturing Problem; High Capture Threshold; Intermittent Capture; Failure to Capture; High impedance; Over-Sensing; Capturing Problem; High Capture Threshold
IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT PROCEDURE, THE PHYSICIAN NOTED A POSSIBLE SETSCREW/HEADER ISSUE AS THEY HAD TROUBLE WITH THE PIN GOING IN THE NEW HEADER. AT A TWO WEEK POST OPERATIVE CHECK, THE PATIENT¿S ALARM WAS SOUNDING. AN INTERROGATION NOTED THAT 3 DAYS POST IMPLANT THERE WAS HIGH UNDEFINED PACING IMPEDANCE, OVERSENSING, INCREASED AND HIGH THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT DURING THE INTERROGATION INTERMITTENT CAPTURE WAS NOTED ON THE RV LEAD. THE LEAD WAS REPROGRAMMED. APPROXIMATELY 1 WEEK LATER THE ALARM SOUNDED AGAIN. EPISODES SHOWED OVERSENSING ON THE RV LEAD. THE LEAD WAS AGAIN REPROGRAMMED. APPROXIMATELY 1 WEEK LATER THE ALARM SOUNDED AGAIN. THE PHYSICIAN DECIDED TO BRING THE PATIENT BACK TO THE CATH LAB TO ATTEMPT TO REPLACE THE RV LEAD, HOWEVER SUBCLAVIAN ACCESS WAS UNSUCCESSFUL. DURING THE PROCEDURE THE PHYSICIAN UNSCREWED AND TRIED TO ADVANCE THE RV LEAD TO MAKE SURE IT WAS NOT A HEADER ISSUE, BUT THE PHYSICIAN SAID THE LEAD WAS ALREADY PASSED THE PIN. NO CAPTURE WAS THEN NOTED ON THE RV LEAD. THE RV LEAD WAS PROGRAMMED OFF AND THE PATIENT IS BEING PACED BY THE LEFT VENTRICULAR (LV) LEAD AS THEY ARE DEPENDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16770760 ↗MalfunctionFeb 13, 2023High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. 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 16363367 ↗InjuryNov 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY WITH LOW IMPEDANCE DURING DEFIBRILLATION THRESHOLD TESTING, CONDUCTED AS PART OF THE IMPLANT PROCEDURE. DURING AN EPISODE OF VENTRICULAR FIBRILLATION (VF) EXTERNAL RESCUE WAS REQUIRED TO TERMINATE THE EPISODE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Ventricular Fibrillation
MAUDE report 15771956 ↗InjuryAug 19, 2022Signal Artifact/Noise; Fracture; High impedance; Impedance Problem; Signal Artifact/Noise; Fracture; High impedance; Impedance Problem
IT WAS REPORTED THAT THERE WAS A LEAD WARNING DUE TO IMPEDANCE VARIABILITY, AND HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) DEFIBRILLATOR AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATOR COILS. 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 15259078 ↗InjuryMay 9, 2022Adverse 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 REMOVED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 14342677 ↗InjuryApr 27, 2021Fracture; High impedance; Over-Sensing; Fracture; High impedance; Over-Sensing
IT WAS FURTHER REPORTED THAT THE RV LEAD WAS EXPLANTED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11732185 ↗MalfunctionMar 17, 2021High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. 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 11504743 ↗InjuryFeb 16, 2021Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Fracture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO RIGHT VENTRICULAR (RV) LEAD OVERSENSING. THE RV LEAD WAS POSSIBLY FRACTURED. A MAGNET WAS APPLIED, AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY. THE RV LEAD WAS 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 11331872 ↗InjuryAug 29, 2019Fracture; High impedance; Fracture; High impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH BIPOLAR AND SUPERIOR VENA CAVA (SVC) IMPEDANCE. A FRACTURE WAS SUSPECTED. 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 8947756 ↗InjuryJul 1, 2019Electrical /Electronic Property Problem; Fracture; High impedance; Device Sensing Problem; Electrical /Electronic Property Problem; Fracture; High impedance; Device Sensing Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH IMPEDANCE AND A SENSING PROBLEM DUE TO A LEAD FRACTURE. THE PATIENT RECEIVED INAPPROPRIATE THERAPY AS A RESULT. THE LEAD WAS 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 8749506 ↗InjuryApr 9, 2019Intermittent Capture; Under-Sensing; Low impedance; Intermittent Capture; Under-Sensing; Low impedance
IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT CAPTURE, LOW PACING IMPEDANCE, AND UNDERSENSING. THE RV LEAD WAS REPROGRAMMED. AN RV LEAD REVISION IS PLANNED; HOWEVER, THE LEAD REMAINS IN USE UNTIL THE PROCEDURE OCCURS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8495735 ↗InjuryApr 3, 2019Over-Sensing; Over-Sensing
IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). FOLLOW UP WAS CONDUCTED AND IT WAS VERIFIED THAT 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 8479724 ↗InjuryMar 8, 2019Over-Sensing; Device Dislodged or Dislocated; Over-Sensing; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. IT WAS NOTED THAT THE RV LEAD WAS SENSING THE ATRIUM AND THE LV LEAD WAS NOT CAPTURING IN ALL CONFIGURATIONS. BOTH LEADS WERE TURNED OFF AND LATER EXPLANTED AND RE PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8404148 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- Cobalt™ XT DR MRI SureScan™ DDPA2D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)3 recalls30 deaths1,603 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page