Viva™ Quad XT CRT-D DTBA1Q1 (UDI 00643169018013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 00643169018013), received between Jun 9, 2016 and Oct 16, 2025 — classified as 6 deaths, 168 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (73 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 236 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S SIBLING THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED 41 SHOCKS TO THE PATIENT APPROXIMATELY FIVE YEARS AGO AND THAT "IT MESSED HIM UP". THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Shock from Patient Lead(s)

  MAUDE report 23308445 ↗
• InjuryJul 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WAS "DEFECTIVE" AND HAD TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566402 ↗
• InjuryJun 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A ¿CHANGE IN THE PATIENT¿S CONDITION.¿ THE PATIENT WAS EXPERIENCING SYNCOPE AND THERE WAS CONCERN THAT THE PATIENT WAS HAVING CARDIAC ARRHYTHMIAS OR DEHYDRATION CAUSING THE SYNCOPE. THE PATIENT WAS INSTRUCTED TO HYDRATE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Dehydration; Syncope/Fainting

  MAUDE report 22213454 ↗
• InjuryDec 11, 2024Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  IT WAS FURTHER REPORTED THAT THE CAUSE OF THE INAPPROPRIATE SHOCKS WAS DETERMINED TO BE DUE TO A TOTAL LEFT SHOULDER ARTHROPLASTY SURGERY AND WERE IN RESPONSE TO THE NOISE OBSERVED ON THE LEAD DURING THE PROCEDURE. IT WAS ALSO NOTED THAT LV LEAD IS PROGRAMMED OFF.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20908653 ↗
• MalfunctionNov 7, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT DURING THE DEVICE UPGRADE PROCEDURE, THE LEADS WERE STUCK IN THE DEVICE HEADER CONNECTOR PORT. THE PHYSICIAN REMOVED THE RUBBER FROM THE DEVICE HEADER AND WAS THEN ABLE TO RELEASE THE LEADS. A NEW DEVICE WAS IMPLANTED, AND THE LEADS WERE CONFIRMED TO BE FUNCTIONING AS INTENDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632349 ↗
• MalfunctionOct 11, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN ABUNDANCE OF PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND THE CLINICIAN SUSPECTED PATIENT WAS IN BRADYCARDIA WHICH WOULD BE BELOW THE PROGRAMMED LOWER RATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20427779 ↗
• InjuryNov 14, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGE OUT PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO REMOVE LEADS FROM HEADER OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). UPON ATTEMPTING TO ENGAGE THE SET SCREW FOR THE LEFT VENTRICULAR (LV) LEAD PORT IN THE CRT-D DEVICE HEADER, THE PHYSICIAN NOTED THAT THE PROVIDED MANUFACTURER'S TORQUE WRENCH WOULD NOT ENGAGE OR LOOSEN THE SET SCREW. A NEW TORQUE WRENCH WAS PROVIDED WITHOUT ANY SUCCESS.  THE PHYSICIAN ATTEMPTED TO USE A NUMBER 2 WHITE HANDLED HEX WRENCH PROVIDED IN MANUFACTURER'S WRENCH KIT AND AGAIN NOTED, COULD NOT ENGAGE OR LOOSEN THE LV PORT SET SCREW. THE PHYSICIAN LOOSENED THE SET SCREWS FOR RIGHT VENTRICULAR (RV) COIL, SUPERIOR VENA CAVA (SVC), RIGHT ATRIAL PACE/SENSE, AND RV PACE/SENSE WITHOUT ISSUE UTILIZING THE PROVIDED TORQUE WRENCH. THE SET SCREW ISSUE WAS NOTED AS POSSIBLY A STRIPPED SET SCREW. THE PHYSICIAN UTILIZED A NEW SERVICE KIT AND, AGAIN ATTEMPTED THE WHITE HANDLED NUMBER 2 HEX WRENCH FROM THE SERVICE KIT, A APPLIED AS MUCH DOWNWARD FORCE AS POSSIBLE AND WAS ABLE TO FINALLY ENGAGE AND LOOSEN THE LV PORT SET SCREW ENOUGH TO REMOVE THE LV LEAD FROM THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136160 ↗
• MalfunctionNov 9, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE AS VENTRICULAR TACHYCARDIA (VT), AND ANOTHER AS VENTRICULAR FIBRILLATION (VF) AND SUBSEQUENTLY PROVIDED INAPPROPRIATE ANTI-TACHYCARDIA PACING FOR THE EPISODES. IT WAS ALSO REPORTED THAT THERE WAS INTERMITTENT ATRIAL UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGM). THE DEVICE AND RIGHT ATRIAL (RA) LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE REMOTE MONITORING NETWORK REPORT CONTAINED RED X'S. TROUBLESHOOTING WAS NOT SPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102177 ↗
• InjurySep 7, 2023Premature Discharge of Battery; Device Sensing Problem; Premature Discharge of Battery; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE CRT-D EXHIBITED NORMAL BATTERY DEPLETION, ELECTIVE REPLACEMENT INDICATOR (ERI) FOR THE GENERATOR CHANGE, NO DEVICE MALFUNCTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703846 ↗
• InjuryAug 3, 2023Failure to Interrogate; Pacing Problem; Appropriate Device Problem Term/Code Not Available; Failure to Interrogate; Pacing Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING. 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 17451645 ↗
• MalfunctionMay 4, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PACING AT A LOWER RATE OF APPROXIMATELY FORTY BEATS PER MINUTE WHICH IS BELOW THE PROGRAMMED LOWER RATE SETTING. IT WAS NOTED THAT THE PATIENT EXPERIENCED DIZZINESS. THE CRT-D REMAINSIN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 16871177 ↗
• InjuryMay 2, 2023Battery Problem; Battery Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED WEAKNESS AND DIZZINESS WHEN STANDING UP FROM A CHAIR. THE PATIENT WAS CONCERNED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY NO LONGER WORKED. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Muscle Weakness/Atrophy

  MAUDE report 16854698 ↗
• InjuryMar 10, 2023Misconnection; Misconnection

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE REPLACEMENT, THE LEFT VENTRICULAR (LV) LEAD WAS STUCK IN THE HEADER OF THE CARDIAC REST MICRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LV LEAD WAS ABLE TO BE REMOVED AFTER SALINE AND THE PUSH AND PULL TECHNIQUE WERE APPLIED. THE CRT-D WAS REPLACED AND THE LV 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 16527051 ↗
• DeathFeb 22, 2023Battery Problem; Battery Problem

  AN ATTORNEY ALLEGES THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT PRESENTED TO FACILITY OFFICE FOR DEVICE INTERROGATION. THE CRT-D INTERROGATION REVEALED THAT "THE BATTERY WAS NOT FUNCTIONING APPROPRIATELY AND THE BATTERY WAS FALLING AND/OR LOW". THE PATIENT WAS SCHEDULED FOR A FOUR MONTH FOLLOW-UP INTERROGATION. APPROXIMATELY, FOUR MONTHS LATER A ROUTINE TRANS THORACIC ECHOCARDIOGRAM AND TREADMILL NUCLEAR TEST WERE PERFORMED AND REVEALED ENLARGED LEFT VENTRICLE. THE NUCLEAR STRESS TEST REVEALED DECREASED LEFT VENTRICLE FUNCTION. APPROXIMATELY, TWO WEEKS LATER THE PATIENT PRESENTED TO THE PHYSICIAN'S OFFICE FOR CARE AND "THE FAULTY AND/OR LOW BATTERY LIFE WAS NOTED". THE PATIENT WAS SCHEDULED FOR A CRT-D INTERROGATION FOR THE FOLLOWING WEEK. HOWEVER, "THE BATTERY ON THE CRT-D RAN OUT AND/OR FAILED TO OPERATE AS INTENDED" THE NEXT DAY AND THE PATIENT EXPIRED.

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

  MAUDE report 16416344 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED AND THAT AN INFECTION OF THE SYSTEM WAS SUSPECTED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. A TEMPORARY PACING SYSTEM WAS IMPLANTED AND THE SYSTEM WAS LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED WHICH NOTED THE PATIENT WAS DIAGNOSED WITH ENTEROCOCCUS FAECALIS BACTEREMIA. VEGETATION WAS ALSO NOTED ON THE RV LEAD. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS FOR ONE WEEK AND THEN ORAL ANTIBIOTICS FOR TWO WEEKS. THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA, VOMITING AND ABDOMINAL PAIN. THE PATIENT WAS FOUND TO HAVE GASTRITIS AND GASTRIC POLYPS BEFORE THE SYSTEM IMPLANT.

  Patient problems: Abdominal Pain; Bacteremia; Gastritis; Nausea; Vomiting

  MAUDE report 16396743 ↗
• InjuryJan 18, 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 INFECTION NOTED AS BACTEREMIA. THE SOURCE OF THE INFECTION WAS IDENTIFIED AS URINARY TRACT INFECTION (UTI). THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS LUGDUNENSIS. IT WAS ALSO REPORTED THAT A ELECTROGRAM (EGM) REVEALED VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 16198938 ↗
• InjuryDec 20, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIGNIFICANT POCKET PAIN. IT WAS DETERMINED A POCKET REVISION WAS NEEDED. AS THE DEVICE WAS APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI) THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 16015059 ↗
• InjuryDec 20, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD SLIPPED DOWN FROM ITS ORIGINAL LOCATION. WHEN THE DEVICE WAS EXPLANTED AND REPLACED, THE PHYSICIAN REPORTEDLY TOLD THE PATIENT THEY WOULD FIX IT WITH THE NEW DEVICE BY PUTTING IN A FEW EXTRA STITCHES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16012877 ↗
• DeathDec 13, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT REPORTED FEELING SHOCKS FROM THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PATIENT WAS IN HOSPICE AT THE TIME OF THE SHOCKS AND THEY WERE CONSIDERING TURNING OFF THE DEFIBRILLATION THERAPIES. THE PATIENT PASSED AWAY APPROXIMATELY FIVE DAYS AFTER THE SHOCKS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 15970190 ↗
• InjuryDec 12, 2022Mechanical Problem; Misconnection; Component Missing; Mechanical Problem; Misconnection; Component Missing

  IT WAS REPORTED THAT WHEN TRYING TO REMOVE THE LEFT VENTRICULAR (LV) LEAD FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HEADER,  THE WRENCH WAS UNABLE TO ENGAGE THE SET SCREW. THE PHYSICIAN REMOVED THE GROMMET, AND PRESUMABLY THE SET SCREW AS THE SET SCREW WAS NEVER FOUND. AT THAT TIME, THE LEFT VENTRICULAR (LV) LEAD WAS VERY DIFFICULT TO REMOVE FROM THE CRT-D HEADER. THE LEAD DID COME OUT AFTER PULLING FOR A FEW MINUTES. THE LEAD TESTED NORMALLY AND REMAINS IN USE. 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 15964464 ↗
• InjuryOct 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY DEPLETED FASTER THAN EXPECTED DUE TO AN INCREASE IN THE LEFT VENTRICULAR (LV) LEAD THRESHOLD. IT WAS CONFIRMED THAT THE LV LEAD HAD DISLODGED. THE LV LEAD WAS PROGRAMMED OFF AND THEN THE LV LEAD AND CRT-D WERE 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 15635354 ↗
• MalfunctionOct 19, 2022Mechanical Problem; Mechanical Problem

  FOLLOW UP INDICATED THAT AFTER BEING REMOVED FROM THE DEVICE, THE LV LEAD WAS FOUND TO BE WORKING AS EXPECTED. THE LEAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633311 ↗
• InjuryAug 31, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A HEART RATE IN THE 30 BEATS PER MINUTE RANGE WHICH IS BELOW THE LOWER PROGRAMMED RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE HEART RATE WOULD THEN RETURN TO NORMAL RANGES. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE HIGH THRESHOLDS. 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 15331519 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION WITH BACTEREMIA AND SEPSIS. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DEMONSTRATED FIBROUS MATERIAL THAT LOOKED LIKE VEGETATION ON THE TIPS ON THE LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. THE LEFT VENTRICULAR (LV) LEAD FRACTURED AT THE DISTAL TIP DURING EXTRACTION AND A SMALL PORTION WAS LEFT IN SITU. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Sepsis

  MAUDE report 15125591 ↗
• InjuryJul 27, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND DEFIBRILLATION THERAPY FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) / ATRIAL TACHYCARDIA (AT) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 15114177 ↗