QUADRA ASSURA MP™ CD3369-40CRecalls & reported problems
St. Jude Medical, Inc. · Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV · Class 3 · Implant
All models of QUADRA ASSURA MP (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Quadra Assura MP is an implanted defibrillator that also paces the heart and delivers shocks to correct fast heart rhythms. Reports mostly describe the device reading electrical signals as heartbeats, and some mention inappropriate shocks, unexpected resets and infections. There are 907 reports, 31 deaths and 279 injuries. No recalls name this device. Reports fell from 69 in the prior 12 months to 37 in the latest 12 months.
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
- 910
- Deaths reported
- 31
- Injuries reported
- 279
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 910 adverse event reports that list this exact device (DI 05414734508346), received between Jun 12, 2018 and Sep 18, 2026 — classified as 31 deaths, 279 injuries, 600 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (456 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-Sensing456
- Adverse Event Without Identified Device or Use Problem157
- Inappropriate/Inadequate Shock/Stimulation69
- Inappropriate or Unexpected Reset50
- Under-Sensing40
- Failure to Capture37
- Signal Artifact/Noise35
- Incorrect Interpretation of Signal32
Patient problems
- No Clinical Signs, Symptoms or Conditions435
- No Known Impact Or Consequence To Patient193
- Unspecified Infection101
- Pocket Erosion41
- No Consequences Or Impact To Patient35
- Arrhythmia26
- Therapeutic Effects, Unexpected23
- Death22
Recent adverse event reports
The 25 most recent of 910 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831605 ↗MalfunctionSep 11, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736875 ↗MalfunctionSep 10, 2026Intermittent Capture
It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited intermittent ventricular capture. No intervention was reported. There were no patient symptoms reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718053 ↗MalfunctionSep 4, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50620450 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with a systemic infection, with Methicillin-Susceptible Staphylococcus aureus (MSSA) bacteremia confirmed by blood cultures and recurrent urinary tract infections (UTIs). The infection was believed to be related to the device. The entire system, including the implantable cardioverter-defibrillator (ICD) and the leads, was explanted. The patient remained in stable condition.
Patient problems: Unspecified Infection
MAUDE report 50492448 ↗MalfunctionAug 19, 2026Over-Sensing
It was reported that the patient presented in clinic. A device interrogation showed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing. Programming changes were made. The patient had no adverse consequences due to the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324427 ↗InjuryAug 13, 2026Insufficient Device Problem Information
It was reported that the patient's ICD was explanted and replaced with a new device. No additional information was provided.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50236962 ↗InjuryAug 7, 2026Migration
It was reported that the patient presented for pocket revision after the implantable cardioverter-defibrillator (ICD) migrated within the pocket leading to skin thinning at the implant site. A subpectoral revision was attempted; however, the procedure could not be completed because of the existing pocket condition and scar tissue. Therefore, the ICD was relocated, and the generator was replaced with new ICD, which was a better fit for the revised pocket. The patient was stable throughout.
Patient problems: Pocket Erosion; Scar Tissue
MAUDE report 50169932 ↗MalfunctionJul 6, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH POST-SENSED T-WAVE OVER-SENSING NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. CORRECTIVE PROGRAMMING CHANGES WERE RECOMMENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25727048 ↗MalfunctionJun 22, 2026Low impedance
IT WAS REPORTED THAT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW DEFIBRILLATION IMPEDANCE, AND RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE. THE EXTERNALIZED CONDUCTOR WAS NOTED ON THE RV LEAD. NO CHANGES OR INTERVENTIONS WERE REPORTED. THE PATIENT'S CONDITION REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25587154 ↗MalfunctionMay 29, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. A REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334559 ↗MalfunctionMay 27, 2026Over-Sensing
IT WAS REPORTED THAT THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT CROSSTALK WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25310756 ↗MalfunctionMay 21, 2026Over-Sensing
IT WAS REPORTED THAT DURING FOLLOW-UP IN CLINIC, THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS), RESULTED IN PACING INHIBITION. PROGRAMMING CHANGES WERE PERFORMED, AND THE PATIENT'S CONDITION REMAINED STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25250520 ↗MalfunctionMay 16, 2026Over-Sensing
IT WAS REPORTED THAT A REMOTE TRANSMISSION FOR THE PATIENT REVEALED CROSSTALK WAS OBSERVED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT WAS BEING MONITORED REMOTELY. THERE WERE NO REPORTED PATIENT SYMPTOMS OR CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25195155 ↗MalfunctionMay 15, 2026Intermittent Capture
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INTERMITTENT VENTRICULAR CAPTURE VIA A REVIEW OF REMOTE TRANSMISSION. SUBSEQUENT REMOTE TRANSMISSION SHOWED THE DEVICE CAPTURING APPROPRIATELY. NO INTERVENTION WAS PERFORMED. NO PATIENT SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185905 ↗MalfunctionMay 4, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING (PPTWOS). PROGRAMMING CHANGES WERE MADE ON (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074673 ↗InjuryApr 15, 2026Inappropriate/Inadequate Shock/Stimulation; Environmental Compatibility Problem; Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE UNDER OFF LABEL CONDITIONS RESULTING IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) GOING INTO BACKUP VVI MODE. AS A RESULT OF THE OFF-LABEL MRI EXPOSURE, THE PATIENT RECEIVED INAPPROPRIATE THERAPY. A NURSE WAS ASSISTED IN REPROGRAMMING THE ICD BACK TO NORMAL SETTINGS. THERE WERE NO OTHER REPORTED PATIENT CONSEQUENCES.
Patient problems: Discomfort
MAUDE report 24891158 ↗InjuryApr 1, 2026Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED 96 PERCENT INAPPROPRIATE MODE SWITCH CAUSED BY OVERSENSING. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760382 ↗InjuryMar 30, 2026Inappropriate/Inadequate Shock/Stimulation; No Apparent Adverse Event
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE THERAPY. NO INTERVENTION WAS REPORTED. THE PATIENT CONDITION WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24725198 ↗InjuryMar 23, 2026Inappropriate/Inadequate Shock/Stimulation; Under-Sensing
IT WAS REPORTED THAT SEVERAL EPISODES OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) WERE NOTED IN A REMOTE TRANSMISSION. REVIEW OF THE MOST RECENT EPISODE NOTED FUNCTIONAL UNDERSENSING. PROGRAMMING CHANGES WERE DISCUSSED BUT NOT MADE AT THIS TIME. NO PATIENT SYMPTOMS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24670664 ↗MalfunctionMar 23, 2026Over-Sensing
IT WAS REPORTED THAT A PATIENT PRESENTED WITH OVER-SENSING NOTED ON THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. CORRECTIVE PROGRAMMING CHANGES WERE MADE. THE PATIENT WAS STABLE THROUGHOUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24659476 ↗MalfunctionMar 19, 2026Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSION REVEALED FAR R OVERSENSING AND INAPPROPRIATE AUTOMATIC MODE SWITCH (AMS) ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). PROGRAMMING CHANGES WERE PERFORMED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641238 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH INFECTION AND SKIN EROSION AT DEVICE POCKET. THE CAUSE OF THE INFECTION WAS NOT IDENTIFIED. ECHOCARDIOGRAPHY SHOWED NO EVIDENCE OF VEGETATION NOTED ON THE LEADS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL LEAD, RIGHT VENTRICULAR LEAD AND LEFT VENTRICULAR LEAD WERE EXPLANTED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 24635665 ↗MalfunctionMar 13, 2026Over-Sensing
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY. REMOTE TRANSMISSION SHOWED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED POST-PACED T-WAVE OVERSENSING. NO INTERVENTION WAS PERFORMED. THE PATIENT HAD NO ADVERSE CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24597859 ↗MalfunctionMar 13, 2026Inappropriate or Unexpected Reset
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE IN BACKUP VVI MODE, RESULTING IN A LOSS OF HIGH VOLTAGE THERAPIES. NO INTERVENTION WAS PERFORMED, AND THE PATIENT'S STATUS WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24591839 ↗
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 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.
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