Viva™ XT CRT-D DTBA1D1 (UDI 00763000059545)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00763000059545), received between Apr 10, 2018 and Jan 28, 2025 — classified as 1 death, 21 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (6 reports).

1 FDA recall record 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. May 10, 2023Class IOpen, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1729-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS APPEARED TO BE FALLING IN BLANKING AT TIMES POSSIBLY TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DEVICE CLASSIFIED TERMINATION OF AT/AF DETECTED EVENT(S) AND OCCASIONAL INAPPROPRIATE ATRIAL PACING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 21252027 ↗
• InjuryJul 12, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing 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 FIBRILLATION (VF); AN ATRIAL ARRHYTHMIA WAS IN PROGRESS AT THE TIME OF THERAPY.  IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED CARDIAC ARREST. THE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE.  THE RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE UNDERSENSING AND THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE OVERSENSING AND UNDERSENSING THAT APPEARED TO RESULT IN INAPPROPRIATE ATRIAL PACING.  THE RV LEAD AND RA LEAD REMAIN IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Shock from Patient Lead(s)

  MAUDE report 19732699 ↗
• InjuryFeb 15, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED FOR NORMAL BATTERY DEPLETION. DURING THE PROCEDURE IT WAS NOTED THE CRT-D WAS ALMOST COMPLETELY ERODING THROUGH THE SKIN. THE CRT-D WAS JUST UNDERNEATH THE VERY THIN DERMIS. THE CRT-D WAS NOT ANCHORED AND HAD RISEN UP HIGH ON THE RIGHT CLAVICLE. THE DEVICE POCKET WAS DEEPENED AND THE NEW DEVICE WAS ANCHORED SO IT WOULD NOT MIGRATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716999 ↗
• DeathJan 9, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD EXPIRED. A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS AND THE HEALTHCARE PROFESSIONAL QUESTIONED WHY THE PATIENT HADN'T RECEIVED THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). FURTHER INFORMATION WAS REQUESTED BUT NOT OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 16123566 ↗
• InjuryNov 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT AT THE IMPLANT PROCEDURE, DURING DEFIBRILLATION THRESHOLD TESTING, TWO SHOCKS WERE DELIVERED, AND SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY. THE VENTRICULAR FIBRILLATION (VF) WAS NOT TERMINATED, AND EXTERNAL RESCUE WAS REQUIRED TO TERMINATE THE ARRHYTHMIA. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 15772051 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING THE LEFT VENTRICULAR (LV) LEAD PROTRUDING FROM THE DEVICE IMPLANT SITE. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH DRAINING OF A CUTANEOUS SINUS TRACT RIGHT ABOVE THE SITE OF THE LEADS AND CONSTANT "SEEPING" FROM THE SITE.THE PATIENT WAS ADMINISTERED ANTIBIOTICS. IT WAS NOTED THAT THE INFECTION WAS ONLY PRESENT ON THE LEADS. A PROCEDURE WAS PERFORMED WITH A PLAN TO REMOVE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM BUT UPON OPENING THE POCKET IT WAS NOTED THAT THE LV LEAD WAS DIRECTLY UNDER THE SITE AND WAS SUSPECTED TO BE CAUSING A POSSIBLE PRESSURE EFFECT LEADING TO IRRITATION AND OPENING OF THE WOUND. THERE WAS NO EVIDENCE OF AN INFECTION IN THE POCKET, BUT THE POCKET WAS IRRIGATED WITH ANTIBIOTIC SOLUTION, THE LEADS WERE NOT REMOVED BUT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PLACED IN AN ANTIBIOTIC ENVELOPE AND RETURNED TO THE POCKET. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. THE CRT-D AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATION

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15275781 ↗
• MalfunctionAug 22, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING. IT WAS NOTED THAT THEY DO NOT SEE ANY PACER SPIKES ON EXTERNAL CARDIAC TELEMETRY. DEVICE APPEARS TO BE CURRENTLY FUNCTIONING AS PROGRAMMED AND 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 15272484 ↗
• InjuryMay 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 14372559 ↗
• InjuryDec 22, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063841 ↗
• InjuryOct 12, 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 A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12615771 ↗
• MalfunctionJun 11, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT TWO ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES APPEARING ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INTERROGATION REPORT APPEARED TO BE DUE TO EXTERNAL NOISE. 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 11982136 ↗
• InjuryMar 22, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED. 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 11541891 ↗
• InjuryFeb 3, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE VERSES VENTRICULAR FIBRILLATION (VF). 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 11272309 ↗
• InjuryJan 29, 2021Electromagnetic Interference; Pacing Problem; Electromagnetic Interference; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) AND WAS NOT SEEING P-WAVES. IN ADDITION, ELECTROMAGNETIC INTERFERENCE FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS OBSERVED. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252974 ↗
• InjuryOct 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE POCKET REVISION WAS PERFORMED DUE TO THE PATIENT COMPLAINING THAT IT WAS PAINFUL.

  Patient problems: Erosion; Pain

  MAUDE report 10711688 ↗
• InjuryJun 22, 2020Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN-CLINIC AND THE CRT-D WAS REPROGRAMMED TO A LOWER DETECTION RATE.

  Patient problems: Ventricular Tachycardia

  MAUDE report 10179828 ↗
• InjuryMay 7, 2020Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) SUPRA VENTRICULAR TACHYCARDIA DISCRIMINATOR USED TO DISTINGUISH BETWEEN RAPID AND GRADUAL ONSET OF FAST VENTRICULAR RHYTHMS MAY HAVE INAPPROPRIATELY WITHHELD HIGH VOLTAGE THERAPY. THE PATIENT WAS THOUGHT TO BE IN A TRUE VENTRICULAR TACHYCARDIA AS THEY WERE REPORTEDLY NEAR SYNCOPE WHILE AT REST. DETECTION ZONES WERE ADJUSTED AND THE FEATURE WAS TURNED OFF. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Ventricular Tachycardia

  MAUDE report 10036757 ↗
• InjuryMar 28, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS AND WAS NOT CAPTURING. THE LEAD WAS CAPPED AND REPLACED. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY DID NOT LAST. 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 9894772 ↗
• InjuryMar 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 9863314 ↗
• InjuryMar 6, 2020Adverse 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 EXTRACTED DUE TO INFECTION. A REPLACEMENT DEFIBRILLATOR SYSTEM WAS IMPLANTED SEVERAL DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9800573 ↗
• InjuryApr 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC FOR A HEMATOMA AND DEHISCENCE OF THE INCISION. THE PATIENT ALSO HAD A POCKET INFECTION. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 8559646 ↗
• MalfunctionApr 25, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DOCTOR WAS UNSATISFIED WITH THE LONGEVITY OBTAINED FROM THE DEVICE. IT WAS NOTED THE DEVICE LASTED ONLY 4.5 YEARS. THE DEVICE 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 8549840 ↗
• MalfunctionApr 17, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE WAS INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8523856 ↗
• InjuryMar 21, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE BEEN INAPPROPRIATELY SHOCKED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS 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 8440899 ↗
• MalfunctionOct 17, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE THE DEVICE WAS INTERROGATED AND THE BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7975789 ↗