QUADRA ASSURA MP™ CD3369-40QRecalls & 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 Quadra Assura MP is an implanted defibrillator that also resynchronizes the heart. The reports often describe the device reading heart signals wrongly, including picking up muscle noise, and sometimes switching to backup mode or resetting. FDA records list 6,076 reports, 103 deaths, 1,370 injuries and 4,603 malfunctions. No recalls name this device. Reports fell from 301 in the prior 12 months to 158 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
- 6,084
- Deaths reported
- 103
- Injuries reported
- 1,374
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6,084 adverse event reports that list this exact device (DI 05414734508377), received between Jun 10, 2018 and Sep 30, 2026 — classified as 103 deaths, 1,374 injuries, 4,607 malfunctions.
The most frequently reported specific device problem is “Over-Sensing” (3,830 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-Sensing3,830
- Adverse Event Without Identified Device or Use Problem833
- Inappropriate or Unexpected Reset363
- Inappropriate/Inadequate Shock/Stimulation303
- Under-Sensing194
- Incorrect Interpretation of Signal150
- Pacing Problem150
- Signal Artifact/Noise129
Patient problems
- No Clinical Signs, Symptoms or Conditions2,734
- No Known Impact Or Consequence To Patient1,709
- Unspecified Infection585
- No Consequences Or Impact To Patient340
- Pocket Erosion135
- Discomfort134
- Arrhythmia130
- Therapeutic Effects, Unexpected126
Recent adverse event reports
The 25 most recent of 6,084 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient had bacteremia and their Implantable Cardioverter Defibrillator (ICD), right ventricular (RV) lead, right atrial (RA) lead, and left ventricular (LV) lead were explanted as a result. The patient was stable.
Patient problems: Unspecified Infection
MAUDE report 50951648 ↗MalfunctionSep 28, 2026Failure to Capture
It was reported that a patient presented remotely via Merlin.net. Review of the transmission revealed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited loss of capture stored as Non-Sustained Right Ventricular Oversensing (NSRVO) episodes. Programming changes were discussed, no changes or interventions were reported. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916103 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented to the clinic for a follow-up visit with pocket infection and device erosion. It was noted that the implantable cardioverter-defibrillator (ICD) had eroded through the skin, with an opening in the skin near the device and associated redness. The physician does not believe infection was device or procedure related. The entire system, including the ICD, right ventricular lead, right atrial lead, and left ventricular lead was explanted. The patient remained in a stable condition.
Patient problems: Pocket Erosion; Unspecified Infection
MAUDE report 50910888 ↗InjurySep 19, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831630 ↗InjurySep 18, 2026Pacing Problem; Pacing Asynchronously; No Apparent Adverse Event
New information received indicates that the Implantable Cardioverter Defibrillator (ICD) was explanted due to Elective Replacement Indicator (ERI).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831091 ↗MalfunctionSep 18, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830865 ↗MalfunctionSep 16, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796985 ↗MalfunctionSep 10, 2026Over-Sensing
It was reported that the patient presented remotely via Merlin.net. Review of the transmission revealed that the implantable cardioverter defibrillator exhibited myopotential oversensing. Further information was requested however, was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719390 ↗MalfunctionSep 9, 2026Over-Sensing
It was reported during remote follow up that the Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing (PPTWOS). The device was reprogrammed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695419 ↗MalfunctionSep 7, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50658550 ↗MalfunctionSep 4, 2026Failure to Interrogate; Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50620601 ↗InjurySep 3, 2026Failure to Deliver Shock/Stimulation; Failure to Convert Rhythm; Under-Sensing
Patient problems: Arrhythmia; Hematoma; Respiratory Failure
MAUDE report 50599180 ↗InjurySep 3, 2026Incorrect Interpretation of Signal; Inappropriate/Inadequate Shock/Stimulation
It was reported that the patient presented remotely via merlin.net. Review of transmission revealed that the Implantable Cardioverter Defibrillator (ICD) delivered inappropriate therapy due to incorrect interpretation of supraventricular tachycardia (SVT). No intervention was performed. There were no patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50591850 ↗MalfunctionAug 31, 2026Over-Sensing
It was reported that the patient presented remotely. A remote transmission showed that the patient's Implantable Cardioverter Defibrillator (ICD) exhibited myopotential 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 50524957 ↗MalfunctionAug 29, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509878 ↗MalfunctionAug 26, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50443115 ↗MalfunctionAug 25, 2026Inappropriate or Unexpected Reset
It was reported that the non-implanted Implantable Cardioverter Defibrillator (ICD) was found to be operating in the backup mode. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435339 ↗MalfunctionAug 24, 2026Over-Sensing
It was reported during in clinic follow up that the Implantable Cardioverter Defibrillator (ICD) exhibited Post-Paced T-wave Oversensing (PPTWOS). Programming changes were successfully implemented. The patient was in stable condition.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411961 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient presented with pocket erosion. It was noted that the device header was superficial, with thin overlying skin. The Implantable Cardioverter Defibrillator (ICD) was explanted and replaced. The patient remained in stable condition.
Patient problems: Pocket Erosion
MAUDE report 50400565 ↗DeathAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient deceased. There is no allegation from a healthcare professional that the death was device related. The cause of death was Congestive heart failure, coronary artery disease, hypertension, atrial fibrillation, diabetes, Chronic obstructive pulmonary disease, and natural causes.
Patient problems: Insufficient Information
MAUDE report 50359003 ↗InjuryAug 20, 2026Inappropriate or Unexpected Reset
It was reported that the patient's Implantable Cardioverter Defibrillator (ICD) went into backup VVI mode, resulting in a loss of high voltage therapies. The ICD was explanted and successfully replaced. The patient remained stable.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358780 ↗MalfunctionAug 20, 2026Over-Sensing
It was reported that the implantable cardioverter defibrillator exhibited far r wave oversensing. Further information was requested however, was not provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50336576 ↗InjuryAug 19, 2026Failure to Convert Rhythm
It was reported that the patient presented with dizziness. It was further reported that their Implantable Cardioverter Defibrillator (ICD) failed to deliver adequate therapy to terminate the arrhythmia. As a result, external defibrillation was performed to restore normal rhythm. The ICD was also explanted and successfully replaced. The patient's status was unknown.
Patient problems: Arrhythmia; Dizziness
MAUDE report 50325777 ↗MalfunctionAug 14, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263289 ↗MalfunctionAug 13, 2026Over-Sensing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50244602 ↗
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
- 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
- Claria MRI™ Quad CRT-D SureScan™ DTMA1QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)22 deaths1,479 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