Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1 (UDI 00643169929555)Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00643169929555), received between Dec 7, 2017 and Oct 7, 2024 — classified as 3 deaths, 34 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (9 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY AND HIGH VOLTAGE THERAPY FROM THE CARDIAC RE SYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE DEVICE WAS REPROGRAMMED TO INCREASE THE VENTRICULAR TACHYCARDIA (VT) DETECTION ZONE AND 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 20386910 ↗
• InjuryMay 6, 2024Failure 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) INAPPROPRIATELY WITHHELD TREATMENT FOR VENTRICULAR TACHYCARDIA (VT) DUE TO A DISCRIMINATION FEATURE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 19255242 ↗
• MalfunctionMar 30, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S CHILD THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING. 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 19009183 ↗
• InjuryMar 28, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 18994234 ↗
• MalfunctionMar 21, 2024Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE DIZZINESS WAS NOT RELATED TO A PRODUCT PERFORMANCE ISSUE AND THE SUSPICION OF THE CRT-D PACING NOT WORKING WAS NOT CONFIRMED.

  Patient problems: Dizziness

  MAUDE report 18951361 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION ACCOMPANIED BY SWELLING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 18349104 ↗
• MalfunctionDec 12, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SUSTAINED HEART RATE IN THE TWENTY BEATS PER MINUTE RANGE. IT WAS NOTED THAT THE CARDIAC RESY NCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO A LOWER PACING RATE OF SIXTY BEATS PER MINUTE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18311692 ↗
• InjuryOct 5, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN INCREASE IN IMPEDANCE AND THRESHOLD MEASUREMENTS. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE 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 17877254 ↗
• MalfunctionJun 15, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD IT WAS NOTED THAT THERE WAS A POSSIBLE VENTRICULAR PACING PAUSE NOTED ON THE ELECTROGRAM (EGM).  THE CRT-D AND RV 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 17140672 ↗
• MalfunctionJan 27, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE INDICATED THAT SHORT CIRCUIT PROTECTION WAS TRIGGERED DURING HIGH VOLTAGE THERAPY AND LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. IT WAS NOTED THAT THE SHOCKS SLOWED THE ARRHYTHMIA BELOW THE DETECTION ZONE BUT DID NOT TERMINATE THE ARRHYTHMIA. 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 16257761 ↗
• DeathNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS SEPTICEMIA AND A CORYNEBACTERIUM AURIMUCOSUM INFECTION. A PROCEDURE WAS UNDERTAKEN TO REMOVE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED PRIOR TO THE PROCEDURE. THE PATIENT WENT INTO MONOMORPHIC VENTRICULAR TACHYCARDIA (VT) DURING TESTING OF A TEMPO RARY PACER. THE PATIENT WAS CARDIOVERTED BACK TO NORMAL SINUS RHYTHM. THE SYSTEM WAS THEN REMOVED. A POST-PROCEDURE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED STABLE-SIZED PERICARDIAL AND PLEURAL EFFUSION AND SEVERAL VEGETATIONS ON THE RIGHT ATRIAL WALL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Pericardial Effusion; Pleural Effusion; Tachycardia; Unspecified Infection

  MAUDE report 15798170 ↗
• InjuryOct 27, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ALGORITHM THAT CONFIRMS THE PRESENCE OF AN ARRHYTHMIA BY COMPARING THE RHYTHM CYCLE LENGTH TO A CALCULATED CONFIRMATION INTERVAL MAY HAVE CONTRIBUTED TO INAPPROPRIATE WITHHOLDING OF HIGH VOLTAGE THERAPY. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 15685459 ↗
• InjuryOct 20, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE FACILITY DUE TO A POSSIBLE INFECTION AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MISFIRING AT HOME. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE OCCASIONAL UNDERSENSED VENTRICULAR BEAT ON STORED ELECTROGRAMS (EGM). THE CRT-D SYSTEM WAS EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection; Ventricular Fibrillation

  MAUDE report 15638664 ↗
• InjuryOct 11, 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 INFECTION OF UNKNOWN ORIGIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15576648 ↗
• InjuryJun 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA OVER THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) OF UNCLEAR ETIOLOGY. IT WAS NOTED THAT THE HEMATOMA WAS NON-RESOLVING DESPITE CONSERVATIVE MEASURES. DEVICE EXPLORATION WAS PERFORMED, AND THE CRT-D WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE HEMATOMA CONTINUED AFTER THE REPLACEMENT PROCEDURE AND LATER RESOLVED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 14738760 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT NOTICED REDNESS AND SWELLING AROUND THE DEVICE AREA. A DEVICE CHECK NOTED THE POCKET WAS SWOLLEN WITH DRAINAGE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Fluid Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 13348010 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A SYSTEMIC INFECTION. THE ENTIRE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. A NEW LEAD WAS IMPLANTED IN THE JUGULAR AND THE EXISTING DEVICE WAS ATTACHED EXTERNALLY TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13196733 ↗
• InjuryDec 20, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITHHELD THERAPY DUE TO A DISCRIMINATOR FEATURE RULE. IT WAS NOTED THAT THE PATIENT WAS IN TRUE VENTRICULAR TACHYCARDIA (VT) BASED ON THE ELECTROGRAMS (EGM). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 13049202 ↗
• InjuryAug 24, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PACING INHIBITION DUE TO OVERSENSING BY THE RIGHT VENTRICULAR (RV) LEAD AND WAS CHECKED INTO THE EMERGENCY ROOM. THE LEAD EXHIBITED SHORT V-V AND NON-PHYSIOLOGIC NOISE EPISODES. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ALSO NOTED WITH PARASITIC CROSSTALK (PHANTOM NOISE) FROM THE PLUGGED LEFT VENTRICULAR (LV) PORT RESULTING IN SOME DISPLAY OF PATIENT RV TIP TO RV COIL SIGNAL. APPROXIMATELY, THREE DAYS LATER, THE CRT-D AND THE RV LEAD WERE 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 12362477 ↗
• InjuryApr 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE EMERGENCY ROOM WITH A FEVER AND FEELING WEAK. THE PATIENT WAS ADMITTED FOR BACTEREMIA. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED VEGETATION ON THE LEADS. THIS WAS PRECEDED BY SORES/ULCER THAT HAD CAUSED A MASSIVE INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Muscle Weakness/Atrophy; Unspecified Infection

  MAUDE report 11701173 ↗
• MalfunctionMar 4, 2021Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED INVALID TREND DATA. 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 11414734 ↗
• InjuryFeb 1, 2021Adverse 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 AND REPLACED DUE TO POCKET INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11258569 ↗
• InjuryJan 20, 2021Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED AN ELECTRICAL RESET. THE RESET WAS CLEARED AND 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 11201730 ↗
• MalfunctionNov 10, 2020Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT TWO DAYS AFTER STORED EPISODES, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH AN ALTERED MENTAL STATUS. A REVIEW OF TRANSMISSION REPORT SHOWED MULTIPLE EPISODES WITH OVERSENSING, AND NOISE ON THE ATRIAL CHANNEL. THE PRESENTATION OF OVERSENSING ON THE ELECTROGRAMS (EGM) WAS SUGGESTIVE OF ELECTROMAGNETIC INTERFERENCE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Code Available

  MAUDE report 10816485 ↗
• InjuryOct 9, 2020Adverse 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10655224 ↗