Quartet™ 1456QRecalls & reported problems
St. Jude Medical, Inc. · Left Heart Lead · Class 3 · Implant
Quick summary
This St. Jude Medical Quartet left heart lead is the wire that runs from an implanted defibrillator to the heart's left ventricle to help it beat in sync. The 49 reports mostly describe the lead failing to capture the heartbeat or shifting out of position, along with pocket infections that required removing the whole implanted system. There is 1 death and 36 injuries. 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
- 49
- Deaths reported
- 1
- Injuries reported
- 36
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05414734510141), received between Jun 21, 2018 and Apr 8, 2026 — classified as 1 death, 36 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Failure to Capture” (13 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Capture13
- Adverse Event Without Identified Device or Use Problem11
- Device Dislodged or Dislocated11
- Capturing Problem5
- High Capture Threshold5
- Break4
- High impedance4
- Therapy Delivered to Incorrect Body Area4
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- No Known Impact Or Consequence To Patient11
- Unspecified Infection7
- Discomfort3
- Vascular Dissection2
- Arrhythmia1
- Death1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC WITH AN INFECTION AT THE IMPLANTED DEVICE POCKET SITE AND POCKET EROSION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALONG WITH THE RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD, AND ATRIAL LEAD WERE OBSERVED TO BE VISIBLE THROUGH THE OPENED DEVICE POCKET INCISION SITE. THE PHYSICIAN EXPLANTED THE ENTIRE SYSTEM TO RESOLVE THE ISSUE. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 24812679 ↗InjuryFeb 13, 2026Failure to Capture
IT WAS REPORTED THAT NO CAPTURE WAS OBSERVED ON THE LEFT VENTRICULAR (LV) LEAD SINCE 2021. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING AND AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24339417 ↗InjuryJul 23, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. IT WAS NOTED THAT THE RIGHT ATRIAL LEAD AND LEFT VENTRICULAR LEAD WERE DISLODGED DUE TO TWIDDLER SYNDROME. BOTH LEADS WERE EXPLANTED AND REPLACED THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22573469 ↗InjuryJul 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION AND WAS EXPERIENCING PAIN AROUND THE INCISION SITE OF THE IMPLANTED DEVICE POCKET. THE PHYSICIAN EXPLANTED THE ACTIVE SYSTEM ¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD AND RIGHT ATRIAL LEAD DUE TO THE INFECTION. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 22409170 ↗MalfunctionJun 12, 2025Break; Separation Failure; Break; Separation Failure
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD FAILED TO BE SEPARATED FROM THE STYLET. IN THE ATTEMPT TO PULL THE STYLET OUT, THE PHYSICIAN DAMAGED THE CONNECTOR PORTION OF THE LV LEAD. THE LV LEAD WAS NOT USED AND WAS REPLACED DURING THE PROCEDURE. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22199828 ↗InjuryApr 29, 2025Failure to Capture; Failure to Capture
IT WAS REPORTED PATIENT PRESENTED FOR A FOLLOW-UP IN THE CLINIC. UPON INTERROGATION, IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE. THE LV LEAD WAS CAPPED AND REPLACED ON (B)(6) 2025. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21924164 ↗InjuryFeb 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-12251. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2025-12252. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. UPON REVIEW, LEAD DISLODGEMENT WAS NOTED ON THE RIGHT ATRIAL (RA), RIGHT VENTRICULAR (RV), AND LEFT VENTRICULAR (LV) LEADS. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RA, RV, AND LV LEADS. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21337243 ↗InjuryOct 16, 2024Capturing Problem; Capturing Problem
IT WAS REPORTED THAT DURING AN IN-CLINIC FOLLOW-UP, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20466475 ↗InjurySep 18, 2024Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC. UPON INTERROGATION, THE LEFT VENTRICULAR (LV) LEAD HAD STIMULATED ACROSS ALL VECTORS AT LOW OUTPUT. THE LV LEAD WAS EXPLANTED BUT WHEN THE PHYSICIAN TRIED TO IMPLANT A NEW LV LEAD, THE LV LEAD WAS UNABLE TO BE IMPLANT. THE LV LEAD WAS NOT IMPLANTED. THE PATIENT WAS STABLE.
Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions
MAUDE report 20253005 ↗InjuryAug 16, 2024Capturing Problem; Capturing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HIGH CAPTURE THRESHOLD. THE LEAD WAS CAPPED. PATIENT STATUS WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19998343 ↗InjuryJun 14, 2024Intermittent Capture; Intermittent Capture
IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED INTERMITTENT CAPTURE AT HIGH OUTPUTS. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR LEAD WAS EXPLANTED. FURTHER INFORMATION WAS NOT PROVIDED. THE PATIENT WAS DISCHARGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19541989 ↗InjuryApr 11, 2024Failure to Capture; Fracture; High impedance; Failure to Capture; Fracture; High impedance
IT WAS REPORTED, THAT PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE AND LOSS OF CAPTURE. LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19093405 ↗MalfunctionMay 26, 2023Use of Device Problem; Use of Device Problem
IT WAS REPORTED THE PATIENT PRESENTED FOR INITIAL PROCEDURE. DURING IMPLANT, THE LEFT VENTRICULAR LEAD WAS UNABLE TO BE IMPLANTED. THE PHYSICIAN ELECTED NOT TO USE THE LEAD. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17015169 ↗MalfunctionMay 3, 2023Break; Break
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-19093. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED EXTRA CARDIAC STIMULATION, INAPPROPRIATE CAPTURE AND INSULATION DAMAGE DUE TO A DISLODGEMENT ON THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LV LEAD. ON THE REPLACEMENT LV LEAD THE PHYSICIAN NOTED INSULATION DAMAGE AND ELECTED TO REPLACE THIS LEAD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865751 ↗InjuryMay 3, 2023Break; Therapy Delivered to Incorrect Body Area; Capturing Problem; Device Dislodged or Dislocated; Break; Therapy Delivered to Incorrect Body Area; Capturing Problem; Device Dislodged or Dislocated
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-19094. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED EXTRA CARDIAC STIMULATION, INAPPROPRIATE CAPTURE AND INSULATION DAMAGE DUE TO A DISLODGEMENT ON THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LV LEAD. ON THE REPLACEMENT LV LEAD THE PHYSICIAN NOTED INSULATION DAMAGE AND ELECTED TO REPLACE THIS LEAD. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16865741 ↗InjuryApr 20, 2023Break; Failure to Capture; High impedance; Break; Failure to Capture; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-18105. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-18106. IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR A FOLLOW UP. DEVICE INTERROGATION REVEALED UNSPECIFIED OVERSENSING, HIGH DEFIBRILLATION IMPEDANCE, HIGH CAPTURE THRESHOLDS AND INSULATION DAMAGE ON THE RIGHT VENTRICULAR (RV) LEAD. DEVICE INTERROGATION REVEALED NOISE OVERSENSING, AUTOMATIC MODE SWITCH, INSULATION DAMAGE AND HIGH CAPTURE THRESHOLDS ON THE ATRIAL (RA) LEAD. DEVICE INTERROGATION REVEALED INSULATION DAMAGE, FAILURE TO CAPTURE AND HIGH CAPTURE THRESHOLDS ON THE RIGHT VENTRICULAR (LV) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LV LEAD. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16782117 ↗MalfunctionMar 20, 2023Failure to Capture; Failure to Capture
IT WAS REPORTED THAT DURING A PROCEDURE THAT THERE WAS LOSS OF CAPTURE ON LEFT VENTRICULAR (LV) LEAD WHICH RESULTING IN HEART RATE PAUSE. NO CHANGES WERE DONE ON THE LEFT VENTRICULAR LEAD. THE PATIENT CONDITION WAS STABLE.
Patient problems: Arrhythmia
MAUDE report 16579526 ↗InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-02565, 2017865-2023-02567. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION AND VEGETATION. THE VEGETATION WAS VISUALIZED WITH TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PHYSICIAN EXPLANTED THE SYSTEM ¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, RIGHT VENTRICULAR LEAD, LEFT VENTRICULAR LEAD, RIGHT ATRIAL LEAD. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: Unspecified Infection
MAUDE report 16200555 ↗InjuryNov 16, 2022Failure to Capture; Failure to Capture
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR A FOLLOW-UP. UPON INTERROGATION, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED A FAILURE TO CAPTURE. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15802752 ↗InjuryOct 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT A PATIENT PRESENTED WITH LEFT VENTRICULAR (LV) LEAD DISLODGED. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE LV LEAD. THE PATIENT CONDITION WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15663075 ↗InjuryAug 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE WHOLE SYSTEM WAS EXPLANTED DUE A RECURRING SEPSIS INFECTION. THE CAUSE OF THE INFECTION WAS UNKNOWN. PATIENT WAS RECOVERING. RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-19298, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-19299, RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-19301.
Patient problems: Unspecified Infection
MAUDE report 15225039 ↗InjuryJul 21, 2022Capturing Problem; Capturing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE LEFT VENTRICULAR LEAD EXHIBITED HIGH CAPTURE THRESHOLD. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2022. THE PATIENT WAS STABLE IN CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15080926 ↗InjuryJun 17, 2022Intermittent Capture; Capturing Problem; Intermittent Capture; Capturing Problem
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-12804; RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-12805. IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY ROOM REPORTING FALLS AND SYNCOPIAL EPISODES. UPON EXAMINATION, THE PATIENT¿S RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEAD WERE FOUND TO HAVE INTERMITTENT LOSS OF CAPTURE. THE LOSS OF CAPTURE WAS ALLEGED ON THE PATIENT¿S PACEMAKER. THE RV AND LV LEADS WERE FOUND TO ALSO HAVE HIGH CAPTURE THRESHOLDS. CORRECTIVE PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: Discomfort; Syncope/Fainting
MAUDE report 14738268 ↗InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING INITIAL IMPLANT WHEN IMPLANTING THE LEFT VENTRICULAR (LV) LEAD IT WAS NOTED THAT THERE WAS DISSECTION OF THE VESSEL. THE LV LEAD WAS NOT USED AND THE PHYSICIAN ELECTED TO COMPLETE THE PROCEDURE WITHOUT A REPLACEMENT. THE PATIENT CONDITION WAS STABLE.
Patient problems: Perforation of Vessels
MAUDE report 14705036 ↗InjuryApr 13, 2022Failure to Capture; Therapy Delivered to Incorrect Body Area; Failure to Capture; Therapy Delivered to Incorrect Body Area
IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR LEAD REVISION. THE LEFT VENTRICULAR (LV) LEAD SHOWED LOSS OF CAPTURE AND THERE WAS PHRENIC NERVE STIMULATION. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14106611 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.