Viva™ XT CRT-D DTBA1D4 (UDI 00643169007239)Recalls & reported problems

Summary

The FDA's MAUDE database contains 374 adverse event reports that list this exact device (DI 00643169007239), received between Feb 9, 2015 and Dec 12, 2025 — classified as 7 deaths, 287 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (131 reports).

2 FDA recall records 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. Feb 3, 2021Class IOpen, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1306-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. 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 374 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS TONING AND UPON INTERROGATION A CHARGE CIRCUIT TIMEOUT WAS NOTED. THE PATIENT IS ON HOSPICE AND THE CRT-D HAD BEEN AT RECOMMENDED REPLACEMENT TIME (RRT) FOR ABOUT A YEAR. 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 23789525 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT APPROXIMATELY FOUR MONTHS AGO, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A STAPHYLOCOCCUS AUREUS INFECTION.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 22501536 ↗
• InjuryNov 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO A MALFUNCTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 20665374 ↗
• MalfunctionAug 26, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT FRIEND THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS BEEN "MISFIRING". 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 20066256 ↗
• MalfunctionJul 1, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D WAS OVERSENSING ON THE ATRIAL CHANNEL DESPITE NO IMPLANTED ATRIAL LEAD. IT WAS NOTED THAT THE OVERSENSING APPEARED TO BE ¿PARASITIC CROSSTALK¿ AND THE DEVICE WAS PICKING UP THE VENTRICULAR CHANNEL. 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 19650306 ↗
• InjuryJun 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) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND WHEN THE PHYSICIAN WENT TO TAKE THE DEVICE OUT OF THE POCKET, PURULENT DISCHARGE FROM THE POCKET WAS NOTED. THE PHYSICIAN CAPPED THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD, CLOSED UP THE POCKET, AND BROUGHT THE PATIENT TO RECOVERY TO DISCUSS THE NEED FOR AN EXPLANT OF THE ENTIRE CRT-D SYSTEM DUE TO A POCKET INFECTION. LATER ON THE SAME DAY, THE PATIENT WAS CRT-D SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 19519475 ↗
• MalfunctionApr 5, 2024Unauthorized Access to Computer System; Unauthorized Access to Computer System

  IT WAS REPORTED BY THE PATIENT THAT SINCE HAVING THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THEY HAVE HAD TO SWITCH OUT THEIR CELL PHONE TEN TIMES BECAUSE THEY KEPT GETTING HACKED. THE PATIENT NOTED THAT IT WAS KNOWN WHEN THEY LOGGED INTO THEIR COMPUTER AND PHONE, AND THEY HAVE PEOPLE FOLLOWING THEM THAT THEY DO NOT KNOW. THE PATIENT HAS REPORTED THE INCIDENT TO THE FEDERAL BUREAU OF INVESTIGATION. THE PATIENT INQUIRED IF THEIR DEVICE COULD BE HACKED. 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 19054605 ↗
• InjuryJan 18, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) RIGHT VENTRICULAR PORT GROMMET HAD BEEN REPLACED WITH MEDICAL GRADE SILICONE ADHESIVE.  THE SETSCREW WAS FOUND TO BE STUCK AND REPORTEDLY STRIPPED AT THE TIME OF DEVICE REPLACEMENT. THE SETSCREW WAS ULTIMATELY REMOVED WITH THE HELP OF AN ADDITIONAL ELECTROPHYSIOLOGIST AND A DIFFERENT WRENCH. 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 18536519 ↗
• MalfunctionOct 14, 2023Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS IMPLANTED AFTER THE USE-BY DATE. THE DEVICE HAS BEEN 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 17936749 ↗
• MalfunctionOct 2, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL "THE PATIENT DEFIB DID NOT FUNCTION VERY WELL."  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 17856051 ↗
• InjurySep 28, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A REPLACEMENT PROCEDURE FOR THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PHYSICIAN REPORTED THE SETSCREW WAS SPINNING IN PLACE. THE GROMMET WAS REMOVED AND THE SETSCREW WAS NOTED TO BE LOOSE. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835217 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVEN AND A HALF YEARS POST CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IMPLANT, THE PATIENT HAD A SMALL SCRATCH ON THE EDGE OF THEIR CRT-D AND A RAISED BLACK AREA OVER THE SITE THAT WAS SUSPICIOUS OF MELANOMA. THE PATIENT W AS SUBSEQUENTLY SEEN BY A DERMATOLOGIST AND DIAGNOSED WITH MALIGNANT MELANOMA AND AT THE TIME THE EXTENT OF THE MELANOMA WAS UNKNOWN. ARRANGEMENTS WERE MADE TO HAVE IT EXCISED AT A TERTIARY CARE CENTER. APPROXIMATELY 3 MONTHS AFTER, THE PATIENT WAS ADMITTED AS THE MELANOMA HAD ULCERATED AND WAS DRAINING. A POCKET INFECTION WAS NOTED. WOUND CULTURES CAME BACK POSITIVE FOR METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE PATIENT WAS STARTED ON INTRAVENOUS (IV) ANTIBIOTICS. FOUR DAYS LATER THE PATIENT UNDERWENT WIDE LOCAL EXCISION OF THE MELANOMA, CRT-D REMOVAL, AND THE LEADS WERE CUT AND CAPPED AS THEY COULD NOT BE SAFELY EXTRACTED. THE PATIENT WAS CONTINUED ON IV ANTIBIOTICS AND HAD AN UNCOMPLICATED RECOVERY. A CHEST COMPUTERIZED TOMOGRAPHY (CT) SCAN SHOWED NO EVIDENCE OF METASTASIS AND THE PATIENT WAS DISCHARGED TO HOME. THE FOLLOWING MONTH THE PATIENT WAS SEEN IN THE OFFICE WHERE IT WAS DETERMINED NOT TO REPLACE THE DEVI

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 17756174 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A TOE INFECTION. AN ECHOCARDIOGRAM SHOWED VEGETATION ON THE LEAD AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. IT WAS ALSO NOTED THERE WAS A CLOT. A NEW CRT-D SYSTEM WAS IMPLANTED APPROXIMATELY 5 MONTHS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 17606949 ↗
• InjuryJun 30, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CRT-D EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI)  AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). IT WAS SUSPECTED THE INAPPROPRIATE THERAPY WAS DUE TO THE EMI AND TWOS.  THE CRT-D AND RV 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 17237158 ↗
• InjuryJun 23, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO N ON-PHYSIOLOGIC OVERSENSING OF ELECTROMAGNETIC INTERFERENCE. THE EPISODE WAS CLASSIFIED 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 17192021 ↗
• MalfunctionMar 9, 2023Battery Problem; Battery Problem

  THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED FOR UNKNOWN REASONS. THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518928 ↗
• MalfunctionFeb 8, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT ELECTROMAGNETIC INTERFERENCE (EMI) WAS OBSERVED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE DEVICE AND LEAD 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 16328734 ↗
• MalfunctionDec 20, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEP LETION, THE RIGHT VENTRICULAR (RV) LEAD WAS LOCKED IN TO THE GROMMET AND THE SETSCREW BECAME UNSCREWABLE. THE PHYSICIAN HAD TO USE SURGICAL PICKUPS TO REMOVE THE PLASTIC PORTION AROUND THE SETSCREW IN ORDER TO FREE THE LEAD. THE CRT-D WAS SUCCESSFULLY 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 16016559 ↗
• InjuryDec 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) RIGHT VENTRICULAR PORT SETSCREW WAS STUCK IN THE HEADER DURING A REPLACEMENT PROCEDURE. AFTER MULTIPLE ATTEMPTS WITH VARIOUS SCREWDRIVERS AND GLUE, THE PHYSICIAN WAS ABLE TO REMOVE THE SETSCREW. 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 15926521 ↗
• MalfunctionDec 5, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGE OUT, THE LEFT VENTRICULAR (LV) LEAD AND RIGHT ATRIAL (RA) LEAD WERE REMOVED FROM DEVICE HEADER WITH EASE. HOWEVER, THE PHYSICIAN COULD NOT SEED THE WRENCH INTO THE SET SCREW FOR THE DF4 RIGHT VENTRICULAR (RV) LEAD THAT WAS DESCRIBED AS "NOT GRABBING". THE PHYSICIAN CONTINUOUSLY ATTEMPTED TO FREE THE RV LEAD AND MOVED THE COVERING OF THE PORT AND EVENTUALLY PULLED THE SET SCREW OUT OF THE SIDE PORT. ONCE THE SET SCREW WAS OUT, THE RV LEAD CAME OUT OF THE HEADER WITH RELATIVE EASE. 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 15918208 ↗
• MalfunctionDec 1, 2022Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO REPORTED THAT INTERMITTENT UNDERSENSING WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD. THE DEVICE AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896763 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM POCKET DRAINAGE WAS NOTED AND ECHOCARDIOGRAM SHOWED POSSIBLE RIGHT ATRIAL (RA) LEAD VEGETATION. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED, FURTHER CULTURE OF THE POCKET POST EXPLANT SHOWED NO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 15834552 ↗
• InjuryNov 11, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT PROCEDURE, TACHYARRHYTHMIA DETECTIONS AND THERAPIES WERE MISTAKENLY NOT DEACTIVATED. THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO SENSING OF ELECTROCAUTERY. THE DEVICE DETECTIONS WERE DISABLED AND THE PROCEDURE COMPLETED WITHOUT INCIDENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 15781603 ↗
• MalfunctionOct 14, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED EXTERNAL ELECTROMAGNETIC INTERFERENCE. 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 15607944 ↗
• InjuryOct 4, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE DEVICE WAS ALLEGED TO HAVE PROVIDED INAPPROPRIATE THERAPY/SHOCKS. A REVIEW OF STORED EPISODES REVEALED THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 15539085 ↗