Viva™ Quad S CRT-D DTBB1Q1 (UDI 00643169530201)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169530201), received between Feb 9, 2017 and Apr 16, 2024 — classified as 11 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 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. 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 ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 12, 2022Battery Problem: Low Impedance; Battery Problem: Low Impedance

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 15785660 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A DEVICE POCKET HEMATOMA STATUS POST MULTIPLE REVISIONS. THERE WAS SLIGHT WOUND DEHISCENCE WITH DRAINAGE. THE PATIENT WAS REFERRED FOR A FULL SYSTEM EXTRACTION DUE TO AN INFECTION THAT DEVELOPED AFTER THE MULTIPLE REVISIONS. A WOUND VACUUM ASSISTED CLOSURE WAS PLACED. THE PATIENT DECLINED A REPLACEMENT SYSTEM AND WORE AN EXTERNAL DEFIBRILLATION SYSTEM. A NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS PLACED TWO YEARS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fluid Discharge; Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 11322484 ↗
• MalfunctionFeb 5, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PATIENT EXPRESSED CONCERN THAT THERE WAS A PROBLEM WITH THE DEVICE. THE PATIENT WAS REFERRED TO THEIR PHYSICIAN AND 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 9671530 ↗
• MalfunctionFeb 3, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE DEVICE DID NOT RECORD/CAPTURE VENTRICULAR FIBRILLATION (VF) EPISODES. 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 9661112 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE EROSION OCCURRED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 9526417 ↗
• InjuryApr 12, 2019Adverse 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) HAD ERODED AND THE SYSTEM WAS SUBSEQUENTLY REMOVED DUE TO INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND RECEIVED A NEW LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 8509618 ↗
• InjuryMar 28, 2019Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). IT WAS NOTED THAT THE VENTRICULAR MORPHOLOGY CHANGED WITH A RATE INCREASE AFTER THE INITIAL SHOCK, WHICH TERMINATED THE ATRIAL ARRHYTHMIA. THE DEVICE IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8460237 ↗
• InjuryJun 27, 2018Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE THERAPY FOR A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEFINED VENTRICULAR TACHYCARDIA (VT) EPISODE. FOLLOW UP WITH THE PATIENT'S CLINIC YIELDED NO FURTHER INFORMATION. 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 7643350 ↗
• MalfunctionMay 30, 2018Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED WITH DIFFICULTY AND REQUIRED EXTERNAL RESCUE. AFTER MULTIPLE ATTEMPTS TO CONVERT VENTRICULAR FIBRILLATION (VF) WITH 10J SAFETY MARGIN WERE NOT SUCCESSFUL THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7555346 ↗
• InjuryMay 10, 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 EXPLANTED - 11 DAYS AFTER A ROUTINE DEVICE REPLACEMENT PROCEDURE - AND LATER REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7502163 ↗
• MalfunctionApr 25, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS INTERROGATED, AND THE BATTERY LONGEVITY STATUS BAR WAS GRAY. IT WAS NOTED THAT THE DEVICE HAD NOT BEEN STORED WITHIN AN INDOOR CONTROLLED TEMPERATURE ENVIRONMENT. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7460035 ↗
• InjuryApr 10, 2018Adverse 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 7418857 ↗
• InjuryApr 10, 2018Adverse 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 AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7415978 ↗
• MalfunctionApr 2, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE WAS INTERROGATED AND THE REMAINING LONGEVITY ESTIMATE GRAPHIC INDICATOR BAR WAS GRAY. IT WAS NOTED THAT THE DEVICE HAD BEEN AT ROOM TEMPERATURE FOR THE THREE DAYS PRIOR. THE DEVICE WAS NOT USED. THERE WAS NO APPARENT PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7389607 ↗
• InjuryDec 7, 2017Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT ONE DAY AFTER A ROUTINE DEVICE UPGRADE FROM A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT), RECEIVED THREE SHOCKS AND ANTI-TACHYCARDIA PACING, AND PRESENTED TO THE EMERGENCY ROOM. THE PHYSICIAN STATED THAT THE CHANGE FROM MINIMAL VENTRICULAR PACING TO PACING MAY HAVE CAUSED THE VT. THE DEVICE WAS REPROGRAMMED TO AVOID RIGHT VENTRICULAR PACING AND IT REMAINS IN USE. IT WAS NOTED THAT THE VT PERSISTED AFTER THE PROGRAMMING CHANGES, AND THE PATIENT WAS STARTED ON MEDICATION; THERE HAS BEEN NO FURTHER VT SINCE THE ANTI-ARRHYTHMIC MEDICATION. THE PATIENT WAS A PARTICIPANT IN THE ATTAIN STABILITY QUAD STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Tachycardia

  MAUDE report 7094383 ↗
• MalfunctionDec 7, 2017Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHEN THE DEVICE PACKAGING WAS OPENED, IT WAS NOTED THE LEFT VENTRICULAR PORT GROMMET WAS MISSING FROM THE DEVICE. THE DEVICE WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7091665 ↗
• InjuryOct 6, 2017Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS CLASSIFYING VENTRICULAR TACHYCARDIA (VT) AS SUPRA VENTRICULAR TACHYCARDIA (SVT) DUE TO GRADUAL ONSET AND WITHHELD THERAPY. THE VT DETECTION ZONE WAS DECREASED SO THAT SLOW VT WOULD FALL INTO THE DETECTION ZONE. THE DEVICE FEATURE WHICH HELPS PREVENT DETECTION OF SINUS TACHYCARDIA AS VT BY EVALUATING THE ACCELERATION OF THE VENTRICULAR RATE WAS ALSO SET TO MONITOR-ONLY. THE PATIENT WAS NON-SPECIFICALLY SYMPTOMATIC DUE TO THE SLOW VT AND WAS TREATED WITH MEDICATION TO RETURN THEM TO NORMAL SINUS RHYTHM. THE DEVICE REMAINS IN USE. A HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLD HAD ALSO BEEN RECENTLY OBSERVED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 6923070 ↗
• MalfunctionFeb 9, 2017High impedance; Mechanical Problem; High impedance; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE WAS PROPHYLACTICALLY BEING REPLACED FOR A DEVICE THAT WOULD ACCOMMODATE A QUADRIPOLAR LEAD. IF A NEW QUAD LEAD COULD NOT BE PLACED, THE PHYSICIAN PLANNED TO CHANGE THE DEVICE TO A COMPETITOR BIPOLAR LEFT VENTRICULAR LEAD DEVICE DUE TO POOR BATTERY LONGEVITY ON THE PATIENT'S CURRENT DEVICE. THE DEVICE WAS EXPLANTED AND THE NEW QUAD LEAD WAS CONNECTED TO THE HEADER OF THE NEW DEVICE AND THE IMPEDANCE WAS HIGH. AFTER RECONNECTING SEVERAL TIMES, THE LEAD CONTINUED TO HAVE HIGH IMPEDANCE. THE DEVICE WAS NOT USED AND THE QUAD LEAD WAS CONNECTED TO A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6321147 ↗