Viva™ XT CRT-D DTBA1D1 (UDI 00643169007246)Recalls & reported problems

Summary

The FDA's MAUDE database contains 893 adverse event reports that list this exact device (DI 00643169007246), received between Dec 9, 2014 and Aug 20, 2026 — classified as 25 deaths, 712 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (328 reports).

1 FDA recall record name this device's identifier.

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. 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 893 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection with sepsis. No further patient complications have been reported as a result of this event.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50357773 ↗
• MalfunctionAug 12, 2026Failure to Charge

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited an alert due to Charge Circuit Timeout.  The CRT-D 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 50227191 ↗
• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE CRT-D 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 23057807 ↗
• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED VIA INTERNAL REVIEW OF HISTORICAL DEVICE DATA TRANSMITTED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR ( CRT-D) THAT INAPPROPRIATE HIGH-VOLTAGE THERAPY WAS DELIVERED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE CRT-D 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 23057757 ↗
• InjuryJan 6, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND AN INAPPROPRIATE SHOCK FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). THE CRT-D 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 21080879 ↗
• InjuryDec 12, 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 REDNESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 20917909 ↗
• InjuryNov 19, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED DUE TO REACHING RECOMMENDED REPLACEMENT TIME (RRT).

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20728145 ↗
• InjuryNov 18, 2024Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20713674 ↗
• DeathAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPIRED AND THE CAUSE OF DEATH WAS NOTED TO CARDIAC ARREST WITH THE ADDITIONAL CIRCUMSTANCES SURROUNDING THE DEATH LISTED AS CARDIOGENIC SHOCK, SEPTIC SHOCK, AND METABOLIC ACIDOSIS/RESPIRATORY ACIDOSIS.

  Patient problems: Cardiac Arrest; Cardiogenic Shock; Respiratory Acidosis; Sepsis

  MAUDE report 20024917 ↗
• InjuryJul 26, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN AND LOW HEART RATES IN THE THIRTY BEATS PER MINUTE (BPM) RANGE. HOWEVER, THE DEVICE LOWER RATE WAS PROGRAMMED TO SIXTY BPM AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD TRIGGERED END OF SERVICE (EOS). ADDITIONALLY, IT WAS DETERMINED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POTENTIAL ATRIAL UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA (AT)/ ATRIAL FIBRILLATION (AF) EVENT(S) AT TIMES AND INAPPROPRIATE ATRIAL PACING. ADDITIONALLY, AN UNDERSENSED BEAT ON STORED ELECTROGRAMS (EGM) WAS NOTED. THE LEAD REMAINS IN USE AND THE CRTD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Chest Pain

  MAUDE report 19839221 ↗
• InjuryJul 12, 2024Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN. THE PATIENT SAID THEIR DEVICE "WASN'T WORKING" AND "NEEDED TO BE REPLACED." THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 19730044 ↗
• InjuryJun 4, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). SUBSEQUENTLY, FIVE DAYS LATER, THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ATP FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CRT-D DETECTED AS VT. ADDITIONALLY, IT WAS NOTED THAT THERE WAS OVERSENSING AND FAR FIELD R-WAVE (FFRW) OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE CRT-D AND RA 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 19460828 ↗
• InjuryMay 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT HAD A FALL.  A QUERY WAS RECEIVED FOR SUSPECTED CRT-D DISLODGE, SYNCOPE AND DIZZINESS.  THE CRT-D REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Fall; Syncope/Fainting

  MAUDE report 19330078 ↗
• InjuryFeb 16, 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 A POCKET INFECTION. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT NOTED THAT THEY HAD LEADS INFECTED ON THE DEFIBRILLATOR. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18721648 ↗
• InjuryFeb 2, 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18636816 ↗
• InjuryJan 23, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564311 ↗
• InjuryJan 11, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY AND POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR FIBRILLATION (VF). ADDITIONALLY, IT WAS NOTED THAT THERE WAS INTERMITTENT UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE CRT-D AND RA 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 18495792 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO AN ENDOCARDITIS INFECTION. VEGETATION WAS ALSO NOTED ON THE TRICUSPID VALVE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Endocarditis; Unspecified Infection

  MAUDE report 18328307 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 18320117 ↗
• MalfunctionOct 20, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL SUSPECTED ABNORMAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FUNCTION. IT WAS NOTED THAT THE PATIENT EXPERIENCED BRADYCARDIA PER THE EMERGENCY MEDICAL SERVICES (EMS). THE PATIENT'S HEART RATE WAS LOWER THAN THE PROGRAMMED PACING RATE OF THE DEVICE. EMS REPORTED HEART RATE IN THE 30S. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 17976654 ↗
• MalfunctionOct 11, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO INTERROGATE. IT WAS NOTED THAT THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) APPROXIMATELY ONE YEAR, NINE MONTHS PRIOR. IT WAS INDICATED THAT CURRENTLY, THE CRT-D BATTERY SHOULD NO LONGER BE ABLE TO SUSTAIN THE DEVICE FUNCTION. THE CRT-D 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 17913613 ↗
• InjurySep 28, 2023Failure to Interrogate; Migration or Expulsion of Device; Pacing Problem; Failure to Interrogate; Migration or Expulsion of Device; Pacing Problem

  IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BRADYCARDIA. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FOUND TO BE AT END OF SERVICE (EOS) AND WAS NO LONGER PACING AND COULD NOT BE INTERROGATED. THE PATIENT WAS NOTED TO HAVE BEEN LOST TO FOLLOW UP. IT WAS FURTHER NOTED THAT AN INFECTION WAS FOUND AT THE DEVICE POCKET. THE DEVICE WAS NOTED TO HAVE MIGRATED AND EROSION WAS PRESENT. THE PATIENT ALSO EXPERIENCED DISCOMFORT, PAIN, PURULENT DISCHARGE/PUS, REDNESS, AND SWELLING. A TEMPORARY PACING SYSTEM WAS UTILIZED AND THE SYSTEM WAS EXPLANTED. A NEW CRT-D SYSTEM WAS IMPLANTED APPROXIMATED A WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Discomfort; Erosion; Erythema; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 17837787 ↗
• MalfunctionAug 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT STATED "DEVICE IS HURTING" AND HEARD A BEEPING.  AN ALLIED HEALTHCARE PROFESSIONAL INDICATED SUSPECTED ABNORMAL DEVICE FUNCTION.  THE CRT-D REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 17442663 ↗
• InjuryJul 20, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO NON-PROPHYLACTIC REASONS. THE DEVICE WAS NOT FUNCTIONING WITH NORMAL TOLERANCES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17363333 ↗
• MalfunctionJul 13, 2023Premature Discharge of Battery; Premature Discharge of Battery

  ADDITIONAL INFORMATION RECEIVED NOTED THAT THE DEVICE WAS EXPLANTED AND REPLACED ELECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321808 ↗