Viva Quad S CRT-DRecalls & reported problems across all models

We found 7 models of Viva Quad S CRT-D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 229 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Aug 20, 2025 — classified as 7 deaths, 156 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (43 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Viva Quad S CRT-D recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 10, 2023Open, 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-1744-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 10, 2023Open, 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-1743-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 · names 4 of these models · Recall details · FDA record ↗

4. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Viva Quad S CRT-D problems

Viva Quad S CRT-D models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Viva™ Quad S CRT-D DTBB1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths101 reports
• Viva™ Quad S CRT-D DTBB1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls1 death43 reports
• Viva™ Quad S CRT-D DTBB1QQ

  Programmer, pacemaker
  2 recalls1 death38 reports
• Viva™ Quad S CRT-D DTBB1Q1

  Programmer, pacemaker
  1 recall20 reports
• Viva™ Quad S CRT-D DTBB1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death12 reports
• Viva™ Quad S CRT-D DTBB1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death8 reports
• Viva™ Quad S CRT-D DTBB1QQ

  Programmer, pacemaker
  7 reports

Recent Viva Quad S CRT-D adverse event reports

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

• MalfunctionAug 20, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE HAD POSSIBLE ARTIFACT/INTERFERENCE NOTED ON ELECTROGRAMS. THE CRT-D 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 22854145 ↗
• 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 17, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ACTIVELY PROVIDING HIGH VOLTAGE THERAPY DESPITE MAGNET APPLICATION. IT WAS CONFIRMED THAT THE HEALTHCARE PROFESSIONAL PLACED THE DONUT MAGNET OVER THE CRT-D, AND IT CAUSED A TONE. 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 22256869 ↗
• DeathSep 24, 2024Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT PASSED AWAY AND ALLEGES THAT "I DON'T THINK IT EVEN WORKED" AND THAT WHEN THE PATIENT PASSED AWAY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT PROVIDE HIGH VOLTAGE THERAPY. THE CAUSE OF DEATH WAS OBTAINED FROM THE CORONERS OFFICE AND NOTED TO BE CARDIAC ARREST DUE TO CORONARY ARTERY DISEASE. ADDITIONAL INFORMATION RELATED TO THE DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Cardiac Arrest

  MAUDE report 20290709 ↗
• MalfunctionApr 23, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT). THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19167027 ↗
• MalfunctionApr 16, 2024Mechanical Problem; Damaged Thread; Mechanical Problem; Damaged Thread

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT, THE SETSCREW COULD NOT BE TURNED AND THE THREADS WERE DAMAGED/STRIPPED. THE DEVICE WAS ABLE TO BE 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 19116819 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A FEVER AND WAS FOUND TO HAVE SEPTICEMIA/SEPSIS AND WAS DIAGNOSED WITH MULTIPLE ORGAN DYSFUNCTION, METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS, BACTEREMIA, THROMBOCYTOPENIA AND INFECTIVE ENDOCARDITIS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND SHOWED EVIDENCE OF VEGETATION ON ONE OF THE LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS AND REQUIRED PRESSOR SUPPORT FOR HYPOTENSION. THE PATIENT WAS NOTED TO HAVE A SMALL PERICARDIAL EFFUSION PRIOR TO THE EXPLANT AND THERE WAS NO CHANGE POST PROCEDURE. OVER THE COURSE OF THE HOSPITALIZATION THE PATIENT DEVELOPED ACUTE ON CHRONIC KIDNEY INJURY RESULTING IN DIALYSIS AND PLACEMENT OF A DIALYSIS CATHETER. ADDITIONALLY, THE PATIENT REQUIRED A BRONCHOSCOPY FOR PNEUMONIA AND WAS DIAGNOSED WITH RESPIRATORY SYNCYTIAL VIRUS PNEUMONITIS. THE PATIENT WAS NOTED TO HAVE A LARGE LEFT PLEURAL EFFUSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Endocarditis; Fever; Low Blood Pressure/ Hypotension; Pericardial Effusion; Pleural Effusion; Pneumonia; Renal Impairment; Sepsis; Thrombocytopenia

  MAUDE report 18895561 ↗
• InjurySep 7, 2023Premature 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17698609 ↗
• InjuryJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THERE WAS A LEAD FAILURE.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 17131012 ↗
• 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 ↗
• DeathMay 11, 2023Battery Problem; Battery Problem

  IT WAS FURTHER REPORTED BY THE FOLLOW UP CLINIC THAT THE CAUSE OF THE PATIENT'S DEATH WAS UNKNOWN AND THERE WERE NO ISSUES NOTED WITH THE BATTERY ON THE PATIENT'S LAST INTERROGATION. IT WAS ALSO NOTED THAT THEY DID NOT SUSPECT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

  Patient problems: Insufficient Information

  MAUDE report 16911717 ↗
• InjuryApr 26, 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. A NEW CRT-D SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16815028 ↗
• MalfunctionApr 14, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT HEART RATE WAS NOTED TO INTERMITTENTLY BE 30-35 BEATS PER MINUTE HOWEVER THE DEVICE PROGRAMMED LOWER RATE IS SET TO 60 BEATS PER MINUTE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 16743722 ↗
• InjuryDec 12, 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 REMOVED DUE TO METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS, SEPSIS, AND BACTEREMIA. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 15957925 ↗
• InjuryNov 22, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED BY A REPRESENTATIVE FOR THE PATIENT THAT THE PATIENT HAD A "TERRIBLE IMPLANTED DEVICE EPISODE (EXPERIENCE);" THE REPRESENTATIVE INDICATED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD "BLOWN UP" IN THE PATIENT'S CHEST AND "SPARKS WERE FLARING OUT OF THEIR CHEST." IT WAS NOTED THE PATIENT WAS BROUGHT TO THE HOSPITAL AND HAD AN EMERGENCY DEVICE REPLACEMENT AS ARESULT OF THE EVENT. ADDITIONAL DETAILS WERE REQUESTED PERTAINING TO THE EVENT, HOWEVER, FOLLOW-UP IS NOT AVAILABLE AT THIS TIME. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15845283 ↗

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