Viva™ XT CRT-D DTBA1D4 (UDI 00643169929302)Recalls & reported problems
Medtronic, Inc. · CRT-D DTBA1D4 VIVA XT US DF4 · Class 3 · Implant
All models of Viva XT CRT-D (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Medtronic Viva XT heart device (CRT-D), an implanted defibrillator that also delivers heart resynchronization therapy. The 38 reports mostly describe the device misreading rhythms, giving shocks when none were needed or withholding needed therapy, sensing problems from lead noise, and batteries draining early. Reports describe 25 injuries and no deaths. One recall, started in December 2017 and closed, concerned a possible prevention of both high and low voltage therapy due to process design.
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
- 39
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00643169929302), received between Oct 6, 2017 and Jul 28, 2026 — classified as 26 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (8 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 Problem8
- Device Sensing Problem8
- Inappropriate/Inadequate Shock/Stimulation8
- Premature Discharge of Battery6
- Over-Sensing4
- Electrical /Electronic Property Problem3
- Electromagnetic Interference3
- Pacing Problem3
Patient problems
- No Known Impact Or Consequence To Patient10
- Shock from Patient Lead(s)8
- No Clinical Signs, Symptoms or Conditions7
- Unspecified Infection6
- No Patient Involvement3
- Erosion2
- No Consequences Or Impact To Patient2
- Arrhythmia1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2026Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation
It was reported that oversensing was noted on the Implantable Cardioverter Defibrillator's (ICD) atrial and ventricular channels due to electromagnetic interference. The patient received high voltage therapies due to the oversensing. The ICD 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 50060112 ↗InjuryOct 15, 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 SHOCKS FOR AN SUPRA VENTRICULAR T ACHYCARDIA (SVT) EVENT 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 23294509 ↗MalfunctionOct 25, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing
IT WAS REPORTED THAT THERE WAS RIGHT VENTRICULAR (RV) LEAD OVERSENSING NOISE WITH A LEAD INTEGRITY ALERT (LIA) FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WHICH WAS ATTRIBUTED TO A LUMBAR FUSION PROCEDURE THAT COINCIDED WITH THE NOTED EPISODES. 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 20533722 ↗InjuryOct 7, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE SUPRA VENTRICULAR TACHYCARDIA (SVT)-ST EPISODE WAS NOTED TO APPEAR SIMILAR TO THE TREATED FAST VENTRICULAR TACHYCARDIA (VT) EPISODE AND WAS INDICATED AS POTENTIAL FOR INAPPROPRIATE WITHHOLDING. THE CRT-D REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR LOW RVTIP TO RVCOIL IMPEDANCE, ADDITIONALLY THE RV LEAD APPEARED TO BE INTERMITTENTLY UNDERSENSING. 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 20384299 ↗InjuryMay 5, 2024Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE 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 19245797 ↗InjuryJun 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED WITH NO REASON FOR EXPLANT. THE DEVICE WAS 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 17117520 ↗InjuryJun 6, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY WITHHELD THERAPY BY THE PATTERN AND RATE ANALYSIS DISCRIMINATE FEATURE FOR THE DETECTION OF VENTRICULAR TACHYCARDIA (VT) THAT WAS CLASSIFIED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD A LEAD POSITION CHECK FAILURE. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Tachycardia
MAUDE report 17072481 ↗InjuryApr 12, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS FURTHER REPORTED THAT THE SHOCKS WERE APPROPRIATE AND THE LOW LV LEAD IMPEDANCE WAS CHRONIC.
Patient problems: Arrhythmia; Shock from Patient Lead(s)
MAUDE report 16727222 ↗InjuryDec 19, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT WAS POSSIBLY SHOCKED INAPPROPRIATELY BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Shock from Patient Lead(s)
MAUDE report 16005512 ↗InjuryMay 5, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED A POTENTIALLY INAPPROPRIATE SHOCK FOR AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE WHICH WAS DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO REPORTED THAT THERE WAS OCCASIONAL UNDERSENSED ATRIAL BEATS NOTED DURING EPISODES. THE CRT-D AND RIGHT ATRIAL (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 14288403 ↗MalfunctionFeb 10, 2022Pacing Problem; Pacing Problem
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED INCREASED THRESHOLDS, UNSTABLE THRESHOLDS AND HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT APPROPRIATELY MODE SWITCHED. THE CRT-D REMAINS IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13508321 ↗InjuryDec 3, 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) WAS EXTRACTED DUE TO INFECTION. THE SYSTEM WAS REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 12923844 ↗InjuryOct 11, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 12605521 ↗InjuryFeb 2, 2021Premature 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 11267138 ↗InjuryJul 31, 2020Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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; No Consequences Or Impact To Patient
MAUDE report 10353107 ↗MalfunctionJul 7, 2020Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing
IT WAS REPORTED THAT OVERSENSING IN THE FORM OF ELECTROMAGNETIC INTERFERENCE WAS OBSERVED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) RIGHT ATRIAL CHANNEL. IT WAS NOTED THAT THE PATIENT WAS IN AN UNGROUNDED SWIMMING POOL DURING MOST OF THE EPISODES. THE CLINICIAN WAS ADVISED THAT REPROGRAMMING COULD NOT ALLEVIATE INTERFERENCE FROM AN EXTERNAL SOURCE. THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10238742 ↗MalfunctionApr 29, 2020Electromagnetic Interference; Electromagnetic Interference
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD ALERTED TWICE DUE TO MAGNET EXPOSURE. THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10009405 ↗MalfunctionApr 12, 2020Unable to Obtain Readings; Unable to Obtain Readings
IT WAS FURTHER REPORTED THAT THE VENTRICULAR TACHYCARDIA (VT) OCCURRED BELOW THE DETECTION ZONE, THERE WERE NO DEVICE DEFICIENCIES, AND THE VT WAS THE RESULT OF PATIENT CONDITION.
Patient problems: Ventricular Tachycardia
MAUDE report 9951888 ↗InjuryFeb 13, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE. THERE WAS A POSSIBLE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT)/ ATRIAL FIBRILLATION (AF) THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE PATIENT WAS IN SVT AND THEN WENT INTO VT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Loss of consciousness; Shock from Patient Lead(s)
MAUDE report 9707666 ↗InjuryJan 15, 2020Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY DEPLETED QUICKER THAN ANTICIPATED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9592589 ↗InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY DEPARTMENT WITH CHEST PAIN WITH NAUSEA, VOMITING, AND DIARRHEA. THE PATIENT WAS ADMITTED FOR SIGNS AND SYMPTOMS OF AN INFECTION AT WHICH POINT THE BLOOD CULTURES AND TEE WERE TAKEN. A TEMPORARY PACEMAKER WAS PLACED AND VEGETATION DEBULKING WAS PERFORMED.
Patient problems: Chest Pain; Diarrhea; Endocarditis; Nausea; Unspecified Infection; Vomiting
MAUDE report 9257654 ↗InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POTENTIAL POCKET EROSION WAS SUSPECTED DUE TO A SUPERFICIAL APPEARANCE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE POCKET WAS REVISED AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Erosion
MAUDE report 9255446 ↗InjuryOct 1, 2019Premature 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 Known Impact Or Consequence To Patient
MAUDE report 9143568 ↗InjurySep 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT DEVELOPED A TEMPERATURE. THERE WAS REDNESS AND DRAINAGE AT THE THORACOTOMY SITE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEADS WERE EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Fever; Unspecified Infection
MAUDE report 9120983 ↗InjurySep 23, 2019Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS RAPIDLY DEPLETING DUE TO HIGH THRESHOLD MEASUREMENTS OF THE LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THAT THE LV LEAD HAD INTERMITTENT LOSS OF PACING CAPTURE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9107022 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
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- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
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- 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 · 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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