Viva™ XT CRT-D DTBA1D4 (UDI 00763000059668)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000059668), received between Aug 24, 2018 and Feb 20, 2024 — classified as 2 deaths, 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (4 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-1731-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD AN UNRESPONSIVE EPISODE AND THE PHYSICIAN FEELS THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS NOT WORKING PROPERLY. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD POSITION CHECK FAILED. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 18741175 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SEPSIS. THE LEFT SIDED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED SECONDARY TO THE INFECTION. THE PRIMARY SOURCE WAS NOTED TO NOT BE DEVICE OR POCKET RELATED, HOWEVER, THE SOURCE IS UNKNOWN. A NEW CRT-D SYSTEM WAS IMPLANTED ON THE RIGHT SIDE 2 WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 17604631 ↗
• InjuryOct 29, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696608 ↗
• MalfunctionNov 19, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FOLLOW UP REVEALED THE ALERT WAS RELATED TO A MISSED REMOTE TRANSMISSION AND AN EPISODE OF ATRIAL FIBRILLATION (AF). THE ALERTS WERE RESET BUT NO OTHER CHANGES WERE MADE TO THE DEVICE SETTINGS.

  Patient problems: Dyspnea

  MAUDE report 12845410 ↗
• InjuryNov 2, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR PREVIOUS DEVICE BATTERY DRAINED FASTER THAN EXPECTED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10771034 ↗
• DeathAug 24, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS AND REQUESTED DEFIBRILLATION THERAPY FROM THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD BE TURNED OFF. THE DEVICE WAS INACTIVATED AT THE PATIENT'S REQUEST AND IT WAS NOTED WITHOUT THERAPY, THE PATIENT LATER PASSED AWAY. THE PATIENT WAS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Death

  MAUDE report 10442877 ↗
• InjuryMar 11, 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 REMOVED DUE TO INFECTION AND DEVICE EROSION THROUGH THE SKIN. PUS DRAINAGE WAS NOTED. CULTURES WERE OBTAINED AND ANTIBIOTICS WERE ADMINISTERED. A NEW CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT

  Patient problems: Discharge; Erosion; Unspecified Infection

  MAUDE report 9818264 ↗
• InjuryMar 4, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS 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 9786924 ↗
• MalfunctionJun 24, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING PRE-IMPLANT DEVICE CHECK, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INTERROGATION DISPLAYED A GRAY BAR INDICATING THE ESTIMATED REMAINING BATTERY VOLTAGE WAS NOT AVAILABLE. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8729473 ↗
• InjuryJun 14, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS A POSSIBLE INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS FAST VENTRICULAR TACHYCARDIA (VT). THERE WAS A HIGH THRESHOLD ALERT ON THE RIGHT ATRIAL (RA) LEAD. 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 8701110 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE DEVICE WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8434616 ↗
• InjuryMar 1, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS CHECKED AS THEY WERE FOUND UNRESPONSIVE. REVIEW OF THE DEVICE DATA INDICATED A HIGH RIGHT ATRIAL (RA) LEAD THRESHOLD. IT WAS NOTED THE PATIENT HAD ALSO EXPERIENCED A SHOCK FOR FAST VENTRICULAR TACHYCARDIA (VT) SEVERAL MONTHS PRIOR FOR WHAT APPEARED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THERE WERE NO CLINICAL ACTIONS NOTED AT THIS TIME. THE RA LEAD AND CRT-D 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 8384006 ↗
• InjurySep 7, 2018Adverse 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 A (B)(6) AND VEGETATION ON THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7857561 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET HEMATOMA AFTER THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT AND THE INCISION DEHISCED. THE CRT-D SYSTEM WAS SCHEDULED FOR REVISION AND THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD LEADS WERE REMOVED. THE LEFT VENTRICULAR (LV) LEAD WAS PARTIALLY EXPLANTED AND THE SYSTEM WAS LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 7834738 ↗
• DeathAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, DEFIBRILLATION TESTING WAS UNSUCCESSFUL. THE PATIENT THEN REQUIRED EXTERNAL DEFIBRILLATION. THE RIGHT VENTRICULAR LEAD WAS REPOSITIONED AND DEFIBRILLATION TESTING WAS AGAIN UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT CONTINUED TO HAVE VENTRICULAR FIBRILLATION WHICH WAS TREATED WITH MEDICATIONS AND EXTERNAL DEFIBRILLATION WITH PLANS TO RETEST AT A LATER DATE. HOWEVER, THE PATIENT PASSED AWAY TWO DAYS LATER. THE CAUSE OF DEATH WAS REQUESTED AND NOT AVAILABLE.

  Patient problems: Death; Ventricular Fibrillation

  MAUDE report 7814889 ↗