Viva™ Quad S CRT-D DTBB1Q1 (UDI 00643169017993)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00643169017993), received between Dec 9, 2016 and Jun 20, 2025 — classified as 1 death, 26 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (8 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 3, 2021Open, 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 · FDA record ↗

2. Dec 19, 2017Terminated

   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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Mechanical Problem; Mechanical Problem

  THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL ERI AND 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 22301790 ↗
• InjuryJun 6, 2023Adverse 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 AN INFECTION. THE CRT-D WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17074795 ↗
• InjuryNov 10, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY WITH LOW IMPEDANCE DURING DEFIBRILLATION THRESHOLD TESTING, CONDUCTED AS PART OF THE IMPLANT PROCEDURE. DURING AN EPISODE OF VENTRICULAR FIBRILLATION (VF) EXTERNAL RESCUE WAS REQUIRED TO TERMINATE THE EPISODE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 15771839 ↗
• MalfunctionOct 11, 2022Communication or Transmission Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO TELEMETRY-RELATED OR OTHER PRODUCT PERFORMANCE ISSUE HAD BEEN IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15574329 ↗
• InjuryAug 25, 2022Adverse 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 15298003 ↗
• InjuryJul 13, 2022Failure to Interrogate; Pacing Problem; Battery Problem; Failure to Interrogate; Pacing Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND ATTEMPTS TO INTERROGATE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WERE UNSUCCESSFUL. A MAGNET WAS PLACED OVER THE DEVICE AND NO AUDIBLE TONE WAS EMITTED AND PACING WAS NOT VISIBLE ON ELECTROCARDIOGRAM (ECG). IT WAS SUSPECTED THAT THE DEVICE WAS AT END OF SERVICE (EOS) OR WITHOUT BATTERY POWER. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15005257 ↗
• MalfunctionJun 23, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNEXPECTED BATTERY DEPLETION. 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 14789091 ↗
• MalfunctionJun 8, 2022Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). IN ADDITION, R WAVE MEASUREMENTS DROPPED SINCE THE AT/AF EPISODES. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN USE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND HAS SINCE BEEN EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14632953 ↗
• MalfunctionJan 10, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION THERE WAS DIFFICULTY RETRACTING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SETSCREW FOR THE LEFT VENTRICULAR (LV) LEAD PORT. MULTIPLE WRENCHES WERE USED BUT THE USER STRUGGLED TO ENGAGE THE DRIVE OF THE SETSCREW. THE LEAD WAS ABLE TO BE REMOVED FROM THE DEVICE HEADER UNDAMAGED AND OPERATIONAL. THE CRT-D WAS EXPLANTED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13209319 ↗
• InjuryAug 24, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND NOISE. THE CAUSE OF THE NOISE COULD NOT BE DETERMINED. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE LEAD WAS CAPPED AND REPLACED. 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 12359440 ↗
• InjuryJun 22, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). IT WAS ALSO NOTED THAT THE PATIENT MAY HAVE RECEIVED AN INAPPROPRIATE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT)/ VENTRICULAR FIBRILLATION (VF). THE LEAD AND DEVICE 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 12041907 ↗
• InjuryJun 4, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEART RATES OF APPROXIMATELY FORTY BEATS PER MINUTE, WHICH WAS BELOW THE LOWER PROGRAMMED RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXHIBITING POSSIBLE INTERMITTENT NON-CAPTURE. THE CRT-D AND LV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 11938796 ↗
• InjuryJun 1, 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 SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF) AND FAST VENTRICULAR TACHYCARDIA (FVT). 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 11913579 ↗
• InjuryOct 13, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS DEPLETING FASTER THAN EXPECTED, POTENTIALLY DUE TO SENSING OF FAST ATRIAL FIBRILLATION (AF). THE DEVICE WAS REPROGRAMMED TO DISCONTINUE AF SENSING AND OUTPUTS WERE ADJUSTED DOWNWARD TO EXTEND 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 10669547 ↗
• InjurySep 28, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS POSSIBLE SHORTER THAN EXPECTED BATTERY LIFE 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 Consequences Or Impact To Patient

  MAUDE report 10592793 ↗
• InjuryJul 10, 2020Signal Artifact/Noise; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS IN A SWIMMING POOL AND RECEIVED A SUSPECTED INAPPROPRIATE SHOCK. IT WAS NOTED A LEAD INTEGRITY ALERT (LIA) TRIGGERED AND ELECTROMAGNETIC INTERFERENCE/NOISE WAS OBSERVED ON ALL ELECTROGRAMS (EGM) OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 10258068 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A ROUTINE DEVICE REPLACEMENT THE PATIENT DEVELOPED AN INFECTION. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND LEADS WERE EXPLANTED. THE SYSTEM WAS REPLACED TWO WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10047608 ↗
• MalfunctionApr 15, 2020Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE BEEN OVERSENSING ELECTROMAGNETIC INTERFERENCE. 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 9962305 ↗
• InjuryMar 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY LIFE WAS DECLINING EARLIER THAN EXPECTED. 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 9901014 ↗
• InjuryMar 4, 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 9787579 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VEGETATION WAS PRESENT ON ONE OF THE IMPLANTED LEADS AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9519818 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9203790 ↗
• DeathApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S SPOUSE CALLED TO REPORT THE PATIENT ¿HAS A STAPH INFECTION ON THE LEADS". CALLER ALSO REPORTED THAT THE PATIENT ALERT TONE WAS GOING OFF MULTIPLE TIMES A DAY. IT WAS FURTHER REPORTED THE PATIENT SUBSEQUENTLY DIED. FOLLOW UP INDICATED THE PATIENT WAS PLACED IN HOSPICE AND HAD THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TURNED OFF. THERE WAS NO OTHER INFORMATION WAS MADE AVAILABLE.

  Patient problems: Death; Unspecified Infection

  MAUDE report 8519153 ↗
• InjuryFeb 22, 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 AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8362720 ↗
• InjuryJan 28, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE HAD REACHED BATTERY DEPLETION PREMATURELY. 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 8282351 ↗