Viva™ XT CRT-D DTBA1D1 (UDI 00643169929296)Recalls & reported problems
Medtronic, Inc. · CRT-D DTBA1D1 VIVA XT US DF1 · Class 3 · Implant
All models of Viva XT CRT-D (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
FDA's MAUDE database lists 65 adverse event reports for the Medtronic Viva XT CRT-D DTBA1D1, an implantable defibrillator that also delivers cardiac resynchronization therapy. Most describe early battery depletion, sensing problems, and inappropriate shocks or pacing; 41 injuries and 1 death are reported. One recall, begun in December 2017 over a design issue that could prevent high or low voltage therapy, was terminated.
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
- 65
- Deaths reported
- 1
- Injuries reported
- 41
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00643169929296), received between Oct 6, 2017 and Feb 5, 2026 — classified as 1 death, 41 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (16 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.
Reports received per month
Recalls naming this device
- 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
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Premature Discharge of Battery16
- Device Sensing Problem10
- Inappropriate/Inadequate Shock/Stimulation10
- Pacing Problem7
- Electrical /Electronic Property Problem6
- Electromagnetic Interference4
- Mechanical Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Unspecified Infection14
- No Known Impact Or Consequence To Patient13
- Shock from Patient Lead(s)10
- No Patient Involvement4
- Arrhythmia2
- Hematoma2
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS, POSSIBLY DUE TO A DEVICE DETECTION ISSUE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 24269275 ↗InjuryDec 17, 2025Adverse 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 23829997 ↗InjuryOct 23, 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 FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 20516737 ↗InjuryJul 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 19732183 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHEN THE PATIENT CAME IN FOR A GENERATOR CHANGE FOR REACHING RECOMMENDED REPLACEMENT TIME (RRT), THE PHYSICIAN NOTICED DISCHARGE AND DISCOLORATION INSIDE THE POCKET. THE PATIENT DID NOT HAVE ANY SYMPTOMS AND THERE WAS NO INDICATION OF AN INFECTION AT SIGHT. THE DEVICE WAS PLACED BACK IN POCKET AND SUTURED CLOSED. CULTURES WERE TAKEN. THE PATIENT WAS SENT TO ANOTHER FACILITY FOR EXTRACTION OF THE ENTIRE SYSTEM. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER DUE TO THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Purulent Discharge; Unspecified Infection
MAUDE report 19458339 ↗InjuryMay 8, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING AND HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF). THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 19270702 ↗InjuryDec 22, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EARLY BATTERY DEPLETION. THE CRTD 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 18384346 ↗MalfunctionDec 15, 2023Pacing Problem; Pacing Problem
IT WAS REPORTED THAT DURING USE OF THE LEFT VENTRICULAR (LV) LEAD IT WAS NOTED THE LEAD EXHIBITED VARIABLE LVTIP TO RV (RIGHT VENTRICULAR) COIL, LEAD IMPEDANCE. THE LV LEAD REMAINS IN USE. ADDITIONALLY THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARIABLE R-WAVE AMPLITUDE. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT WAS HAVING A LOT OF ECTOPY AND PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND THERE WAS CONCERN REGARDING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), VENTRICULAR SENSE RESPONSE PACING. 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 18334812 ↗InjuryMar 2, 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 REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 16469486 ↗MalfunctionJan 26, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS CONCERNED REGARDING A DROP IN LONGEVITY ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 16248622 ↗MalfunctionJan 25, 2023Pacing Problem; Pacing Problem
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AT TIMES. THE LV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT HEART RATES ARE BELOW THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE OF 50 BEATS PER MINUTE (BPM). THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT.
Patient problems: Ectopic Heartbeat; No Clinical Signs, Symptoms or Conditions
MAUDE report 16244247 ↗InjuryDec 15, 2022Pacing 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 SHOCKS FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. IT WAS NOTED THAT THE CRT-D WAS IN MODE SWITCH AT THE TIME OF THE DETECTION. 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 15991972 ↗DeathNov 22, 2022Failure to Deliver Shock/Stimulation; Battery Problem; Failure to Deliver Shock/Stimulation; Battery Problem
IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT DELIVER A SHOCK WHEN THE PATIENT EXHIBITED AN IRREGULAR HEARTBEAT. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Arrhythmia
MAUDE report 15844491 ↗InjurySep 20, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT POTENTIALLY RECEIVED INAPPROPRIATE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS FAST VENTRICULAR TACHYCARDIA. THERE WAS A POSSIBLE CAPTURE ISSUE NOTED ON THE RIGHT VENTRICULAR (RV) LEAD AS THE CAPTURE THRESHOLD WAS HIGHER THAN THE PROGRAMMED OUTPUT. THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE CRT-D, RV LEAD, 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 15455614 ↗InjuryAug 12, 2022Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 15221699 ↗MalfunctionJul 21, 2022Electromagnetic Interference; Electromagnetic Interference
IT WAS REPORTED THAT ATRIAL FIBRILLATION (AF) ELECTROGRAMS (EGM) SHOWED NOISE ON THE RIGHT ATRIAL (RA) LEAD THAT WAS MOST LIKELY ELECTROMAGNETIC INTERFERENCE. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15075468 ↗InjuryFeb 3, 2022Adverse 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 REMOVED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 13446501 ↗InjuryDec 15, 2021Adverse 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 INFECTION. IT WAS ALSO NOTED THAT DURING THE REMOVAL OF THE LEFT VENTRICULAR (LV) LEAD IT "SNAPPED" AND WAS ONLY PARTIALLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 13011255 ↗InjuryNov 12, 2021Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing
SENSITIVITY WAS DECREASED AND THE DEVICE REMAINS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12804585 ↗InjuryNov 12, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION LIKELY DUE TO HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LV LEAD 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 12804549 ↗InjuryOct 19, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED AND THE RV LEAD 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 12656976 ↗MalfunctionOct 13, 2021Pacing Problem; Pacing Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER SENSING WHICH LEAD TO INHIBITION OF PACING BY THE CARDIAC RESYNC HRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LEAD AND DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 12628845 ↗InjuryAug 3, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL WITH VENTRICULAR TACHYCARDIA (VT) STORM, AND REPORTED THAT THE SHOCKS WERE APPROPRIATE.
Patient problems: Shock from Patient Lead(s)
MAUDE report 12266697 ↗InjuryJun 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A POCKET REVISION PROCEDURE SIGNS OF AN INFECTION WERE NOTED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO THE INFECTION. WHILE REMOVING THE LEFT VENTRICULAR (LV) LEAD THE PATIENT EXPERIENCED A PERFORATION. THE PATIENT SUBSEQUENTLY DEVELOPED TAMPONADE AND PLEURAL EFFUSION. A STERNOTOMY WAS PERFORMED AND THE PATIENT WAS PUT ON BYPASS AND HAD TO RECEIVED UNITS OF BLOOD. THE PATIENT WAS IN CRITICAL CONDITION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 11939271 ↗InjuryJun 2, 2021Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD EARLY BATTERY DEPLETION. THE DEVICE 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 11921278 ↗
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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 · each recall links to the FDA recall notice
- 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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