Viva™ Quad XT CRT-D DTBA1QQ (UDI 00643169007222)Recalls & reported problems

Summary

The FDA's MAUDE database contains 620 adverse event reports that list this exact device (DI 00643169007222), received between Dec 9, 2016 and Nov 20, 2025 — classified as 19 deaths, 450 injuries, 151 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (183 reports).

2 FDA recall records name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 3, 2021Class IOpen, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1306-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 19, 2017Class ITerminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0584-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 620 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT A FULL ELECTRICAL RESET OCCURRED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE PATIENT EXPERIENCED BRADYCARDIA. THE DEVICE WAS LATER EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI)/END OF SERVICE (EOS). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23607454 ↗
• InjuryNov 5, 2025Failure to Interrogate; Failure to Interrogate

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477578 ↗
• MalfunctionJul 1, 2025Battery Problem; Battery Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371802 ↗
• MalfunctionMar 19, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE CLINICIAN BELIEVED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ONLY PACING AT FORTY BEATS PER MINUTES WHEN THE DEVICE'S PROGRAMMED LOWER RATE WAS SET TO SIXTY BEATS PER MINUTE. THE DEVICE 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 21646057 ↗
• InjuryMar 6, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE PATIENT WAS PRESCRIBED ANTIARRHYTHMIC MEDICATION AND REPROGRAMMING WAS DONE MULTIPLE TIMES THE DEVICE WAS EXPLANTED AND REPLACED, AND AN ATRIOVENTRICULAR NODE ABLATION WAS DONE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21537246 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION AND POCKET EROSION. THE CRT-D AND RIGHT VENTRICULAR (RV) LEAD WERE SUBSEQUENTLY REPLACED FOUR DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 20758254 ↗
• InjurySep 30, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED PATIENT COMFORT MEASURES WERE TAKEN AND DEVICE TURNED OFF. NO EVENTS IN CHART TO ALIGN WITH THE REPORTED CRT-D, RA LEAD AND RV LEAD REPORTED ISSUES.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20340752 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION INVOLVING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD AN ARTIFACT ON STORED ATRIAL ELECTROGRAMS (EGM). THE ATRIAL SENSITIVITY WAS REPROGRAMMED, AND THE LEAD WAS LATER EXPLANTED AND REPLACED. THE CRTD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20270880 ↗
• InjuryJul 1, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR THE DETECTION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE THAT WAS IN PROGRESS AT THE TIME AND WAS CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARS TO POTENTIALLY UNDERSENSE TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19650464 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A TRANSCATHETER PACING SYSTEM. APPROXIMATELY ONE MONTH LATER A NEW CRT-D SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19608199 ↗
• DeathMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN A USUAL STATE OF HEALTH, HAD A MECHANICAL FALL AT THEIR HOME, WAS FOUND THIRTY-SIX HOURS LATER BY A CAREGIVER, AND BROUGHT TO THE EMERGENCY DEPARTMENT. THE PATIENT WAS FOUND TO HAVE HYPERKALEMIA DUE TO MISSING DIALYSIS. THE PATIENT PRESENTED IN SHOCK WITH COMPONENTS OF HYPOVOLEMIA, SEPSIS, AND CARDIOGENIC SHOCK. THE PATIENT WAS GIVEN FLUIDS AND ANTIBIOTICS AND UNDERWENT DIALYSIS. FOLLOWING THE PATIENT¿S ADMISSION TO THE EMERGENCY DEPARTMENT, THE PATIENT¿S MENTAL STATUS DECLINED, A CHEST COMPUTERIZED TOMOGRAPHY (CT) SHOWED POSSIBLE RIGHT ATRIAL (RA) LEAD VEGETATION OR THROMBUS, AND THEIR BLOOD CULTURES WERE NEGATIVE. THE PATIENT WAS PLACED ON COMFORT CARE AND SUBSEQUENTLY PASSED AWAY NINE DAYS LATER AND THE CAUSE OF DEATH WAS NOTED TO BE END STAGE RENAL DISEASE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Cardiogenic Shock; Fall; Hyperkalemia; Hypovolemia; Renal Failure; Sepsis

  MAUDE report 19381249 ↗
• InjuryMay 7, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A GENERATOR REPLACEMENT PROCEDURE, THE SETSCREWS FOR THE CHRONIC CARDIAC RESYNCHRONIZATION THERAPY DEFIB RILLATOR'S (CRT-D) RIGHT AND LEFT VENTRICULAR PORTS WERE DISENGAGED. THE LEADS WERE ABLE TO BE PULLED OUT OF THE DEVICE WITHOUT UNSCREWING THE SETSCREWS. THE CRT-D WAS 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 19262187 ↗
• InjuryMar 13, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS FURTHER REPORTED THE CRT-D WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18895671 ↗
• InjuryMar 7, 2024Pacing Problem; Pacing Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT'S "UNRESPONSIVE EPISODE" AND BRADYCARDIA ARE LIKELY DUE TO A PRODUCT PERFORMANCE ISSUE. MEDICS REPORTED PATIENT HEART RATE THE TWENTIES WHILE ON THE WAY TO THE EMERGENCY ROOM AND NOTES FROM ONCE THE PATIENT WAS IN THE EMERGENCY ROOM ALSO STATE HEART RATE IN THE TWENTIES. HOWEVER, DEVICE HISTOGRAM DATA CHECK DID SHOW SOME VENTRICULAR RATES BELOW THE LOWER RATE SETTING OF 60 BEATS PER MINUTE (BPM), BUT ONLY A SMALL BUCKET¿S WORTH AND ONLY DOWN TO 50-60 BPM RANGE. ATRIAL HISTOGRAM DID SHOW MORE LOWER RATES VERSUS VENTRICULAR HISTOGRAM. RECOMMENDED REPLACEMENT TIME (RRT) HAD BEEN REACHED IN THE PRIOR MONTH. NOTES FROM SUBSEQUENT ADMISSION THE PHYSICIAN QUESTIONED EARLIER CAUSE OF INITIAL SYNCOPE, STATING THIS WAS ¿A DIFFICULT CASE THAT HAD EXTENSIVE WORK-UP WITHOUT OBVIOUS ETIOLOGY. THE BRADYCARDIA ISSUE WAS RESOLVED AND SUBSEQUENT REMOTE DEVICE CHECK, POST GENERATOR CHANGE OUT, SHOWED PROPER FUNCTION OF DEVICE.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 18858379 ↗
• InjuryMar 1, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED POTENTIALLY INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE DETECTED BY THE DEVICE AS VENTRICULAR FIBRILLATION (VF). THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18822354 ↗
• InjuryFeb 27, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT HAD SUPRA VENTRICULAR TACHYCARDIA (SVT) AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ANTI-TACHYCARDIA PACING AND A SHOCK FOR VENTRICULAR FIBRILLATION (VF). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18793234 ↗
• InjuryFeb 21, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED, THAT PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, DUE TO SYNCOPE/NEAR SYNCOPE.  IT WAS NOTED, THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT RECEIVED SUSPECTED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY, DURING A ATRIAL FIBRILLATION (AF). EPISODES THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF).  THE ATP THERAPY PROVIDED ACCELERATED, THE VENTRICULAR RATES, FOR WHICH THE PATIENT RECEIVED SUSPECTED INAPPROPRIATE HIGH VOLTAGE THERAPY.  THE CRT-D REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Syncope/Fainting

  MAUDE report 18754490 ↗
• MalfunctionJan 30, 2024Battery Problem; Battery Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE AN UNKNOWN REASON. THE CRT-D SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608042 ↗
• InjuryJan 4, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED INAPPROPRIATE HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE CRT-D AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18446031 ↗
• InjuryDec 5, 2023Pacing Problem; Battery Problem; Pacing Problem; Battery Problem

  IT WAS FURTHER REPORTED THAT THERE WAS NO ISSUE WITH THE CRT-D BATTERY. THE DEVICE HAS BEEN IMPLANTED FOR EIGHT YEARS AND HAD TWO MONTH BATTERY REMAINING. THE CRT-D WAS REPROGRAMMED.

  Patient problems: Syncope/Fainting

  MAUDE report 18270460 ↗
• InjuryNov 14, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS SIMILAR TO VENTRICULAR TACHYCARDIA (VT), BUT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD NOT RECORDED ANY VT EPISODES. IT WAS NOTED THAT THE PATIENT EXPERIENCED A FLUSHED FEELING, SWEATS, HEAVINESS IN THEIR FACE, NAUSEA, AND A HEADACHE. IT WAS ALSO NOTED THAT THERE WAS A DECREASE IN BIVENTRICULAR PACING. THE CRT-D WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Diaphoresis; Headache; Nausea

  MAUDE report 18131305 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18107385 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A SYSTEMIC INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17837224 ↗
• InjurySep 18, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17765945 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AND WAS FEELING TIRED, FATIGUED, AND CHILLS. IT WAS NOTED THE THE PATIENT'S WHITE BLOOD CELL COUNT WAS ELEVATED AND THERE WAS ENDOCARDITIS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED RIGHT ATRIAL (RA) LEAD VEGETATION ALONG WITH MITRAL VALVE AND TRICUSPID VALVE VEGETATION. MEDICATIONS WERE ADMINISTERED PRIOR TO THE SYSTEM EXPLANT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Bacteremia; Chills; Endocarditis; Fatigue; Sepsis; Unspecified Infection

  MAUDE report 17546572 ↗