Viva™ Quad XT CRT-D DTBA1Q1 (UDI 00643169720190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00643169720190), received between Jan 18, 2019 and May 14, 2026 — classified as 1 death, 16 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (7 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-1732-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• DeathMay 14, 2026Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S RELATIVE THAT THE PATIENT PASSED AWAY AND THE DOCTOR WAS REPORTEDLY SURPRISED THAT THE CARDIA CRESY NCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT "GO OFF". IT WAS ALLEGED THAT THE DEVICE WAS RELATED TO THE PATIENT'S DEATH. ADDITIONAL INFORMATION WAS SOUGHT BUT COULD NOT BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 25174714 ↗
• InjuryFeb 12, 2024Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS FURTHER REPORTED THAT THE RV LEAD HAD FRACTURED. NO CHANGES WERE MADE TO THE DEVICE SETTINGS.

  Patient problems: Shock from Patient Lead(s); Ventricular Fibrillation

  MAUDE report 18686728 ↗
• MalfunctionJan 31, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A DROP IN BATTERY ESTIMATION.  IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD A SLOW RISE IN PACING THRESHOLD MEASUREMENTS.  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 16274065 ↗
• InjuryAug 10, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT FELT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MOVING IN THE POCKET AND SUSPECTED THEIR LEADS WERE MOVING OR COMING OUT. THE PATIENT WAS SUBSEQUENTLY EVALUATED FOR POTENTIAL POCKET EROSION AND THE SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 15200823 ↗
• InjuryFeb 28, 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 BATTERY DEPLETION AND EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620226 ↗
• InjuryOct 8, 2021Signal 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 FURTHER REPORTED THAT THE DEVICE SETTINGS WERE ADJUSTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 12597118 ↗
• InjuryJun 18, 2021Failure 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) DISCRIMINATION FEATURE WHICH DISTINGUISHES BETWEEN RAPID AND GRADUAL ONSET OF FAST VENTRICULAR RHYTHMS WITHHELD DEFIBRILLATION THERAPY FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS CLASSIFIED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE RHYTHM WAS NOTED TO BE IN THE THERAPY ZONE ALTHOUGH IT WAS NOTED TO BE GOING IN AND OUT OF THE THERAPY ZONE AT TIMES. THE PATIENT WAS HOSPITALIZED AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 12023595 ↗
• InjuryJun 11, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE RHYTHM WAS CONFIRMED TO BE VENTRICULAR TACHYCARDIA (VT) AND THERAPIES WERE DEEMED APPROPRIATE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 11984142 ↗
• InjuryMay 10, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED AN INAPPROPRIATE SHOCK FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH A RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE 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 11797845 ↗
• InjuryFeb 23, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED AN INAPPROPRIATE SHOCK FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH A RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE 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 11365455 ↗
• MalfunctionFeb 18, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING A PRE-IMPLANT DEVICE CHECK, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT UPON DEVICE INTERROGATION. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343109 ↗
• MalfunctionDec 21, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046093 ↗
• InjuryNov 24, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10896797 ↗
• InjuryNov 11, 2020High impedance; Mechanical Problem; High impedance; Mechanical Problem

  IT WAS REPORTED THAT THE DAY AFTER THE PATIENT¿S GENERATOR CHANGOUT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND UNDEFINED PACING IMPEDANCE. AN X-RAY CONFIRMED THAT THE RV PACE/SENSE LEAD WAS NOT INSERTED PAST THE PIN BLOCK OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). REPROGRAMMING WAS DONE AND THE PHYSICIAN REQUESTED FREQUENT MONITORY AS THE PATIENT WILL BE SCHEDULED FOR A REVISION IN TWO MONTHS TO DECREASE RISK OF INFECTION FROM EARLY INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10823282 ↗
• InjurySep 15, 2020Failure 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), A VENTRICULAR TACHYCARDIA (VT) EPISODE WAS INAPPROPRIATELY CLASSIFIED AS A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE, AND THERAPY WAS INAPPROPRIATELY WITHHELD. IT WAS NOTED THAT THE DEVICE FEATURE THAT USES PATTERN AND RATE ANALYSIS TO DISCRIMINATE BETWEEN SVT AND TRUE VENTRICULAR TACHYARRHYTHMIAS WAS TURNED OFF. THE CRT-P 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 10535800 ↗
• MalfunctionJul 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LESS THAN EXPECTED REMAINING LONGEVITY. THE DEVICE 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 10347579 ↗
• InjuryJul 28, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SET SCREW WAS LOOSE AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT OF RANGE, PACING AND DEFIBRILLATION IMPEDANCES APPROXIMATELY ONE MONTH POST-IMPLANT. THE CRT-D AND RV LEAD WERE REVISED AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10333406 ↗
• InjuryJun 16, 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 (CRT-D) DETECTED AN EPISODE OF SLOW VENTRICULAR TACHYCARDIA (VT) AS SUPRA VENTRICULAR TACHYCARDIA (SVT) AND INAPPROPRIATELY WITHHELD THERAPY. IT WAS SUSPECTED THAT THE INAPPROPRIATE DETECTION MAY HAVE BEEN DUE TO THE CRT-D FEATURE THAT FUNCTIONS AS A SVT DISCRIMINATOR AND IS USED TO DISTINGUISH BETWEEN RAPID AND GRADUAL ONSET OF FAST VENTRICULAR RHYTHMS. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. THE CRT-D AND THE RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Tachycardia

  MAUDE report 10160824 ↗
• MalfunctionMar 24, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT UPON INITIAL INTERROGATION THE DEVICE LONGEVITY COULD NOT BE CALCULATED DUE TO COLD. THE DEVICE HAD NOT BEEN STORED AT TEMPERATURES BELOW FREEZING AND HAD BEEN AT ROOM TEMP FOR SIX HOURS PRIOR TO INTERROGATION. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9874513 ↗
• MalfunctionMar 23, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE RIGHT ATRIAL GROMMET ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WOULD NOT ENGAGE THE SET SCREW. MULTIPLE WRENCHES WERE ATTEMPTED. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9868185 ↗
• MalfunctionFeb 3, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9661318 ↗
• MalfunctionJan 23, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY DID NOT MEET INDICATIONS FOR IMPLANT UPON DEVICE INTERROGATION. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9623231 ↗
• MalfunctionDec 17, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY DID NOT MEET INDICATIONS FOR IMPLANT ON TWO SEPARATE OCCASIONS. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9481198 ↗
• InjurySep 6, 2019Electromagnetic Interference; Pacing Problem; Electromagnetic Interference; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPOSED TO ELECTROMAGNETIC INTERFERENCE (EMI) WHILE THE PATIENT WAS SWIMMING, RESULTING IN PACING INHIBITION. THE PATIENT HAD EXPERIENCED DIZZINESS AND ULTIMATELY LOST CONSCIOUSNESS. NO ACTION WAS TAKEN BUT ENVIRONMENTAL EMI TESTING MAY BE CONDUCTED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Syncope

  MAUDE report 8970226 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8921343 ↗