Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ (UDI 00643169929562)Recalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 00643169929562), received between Oct 6, 2017 and Mar 16, 2026 — classified as 5 deaths, 137 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (29 reports).

1 FDA recall record name this device's identifier.

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. 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-0586-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 194 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT LEAD TO WAVELET NOT BEING APPLIED. ADDITIONALLY, THE PATIENT POSSIBLY RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY AND SHOCKS FOR AN EPISODE OF SUPRA VENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE RA LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 24607536 ↗
• InjuryJan 9, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WAS EXPLANTED AND REPLACED DUE TO "BATTERY FAILURE." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019991 ↗
• InjuryDec 10, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT ABOUT THREE YEARS AGO THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD. SHOCKED THEM FOUR TIMES. THE PATIENT PRESENTED TO THE HOSPITAL AND WAS TOLD THAT THEIR LIMITS MAY HAVE NOT BEEN SET CORRECTLY AND HENCE THE THERAPY GIVEN. 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 23772807 ↗
• InjurySep 3, 2025Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem

  IT WAS FURTHER REPORTED REPROGRAMMING WAS COMPLETED.

  Patient problems: Tachycardia

  MAUDE report 22957299 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION IN THE BLOOD STREAM AND A FEVER. THE ENTIRE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 22908039 ↗
• InjuryJul 30, 2025Pacing 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 SHOCK THERAPY FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/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 22669474 ↗
• InjuryApr 18, 2025Adverse 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 SUSPECTED POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 21866284 ↗
• InjuryMar 4, 2025Failure 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) WAS INAPPROPRIATELY WITHHOLDING THERAPY FOR VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THAT THE SUPRA VENTRICULAR TACHYCARDIA (SVT) ATRIAL FIBRILLATION (AF) AND ATRIAL FLUTTER DISCRIMINATORS AS WELL AS THE FEATURE DESIGNED TO WITHHOLD INAPPROPRIATE VENTRICULAR DETECTION IF THE RHYTHM DISPLAYS CHARACTERISTICS OF AN SUPRA VENTRICULAR TACHYCARDIA (SVT) ORIGIN WERE INAPPROPRIATELY WITHHOLDING THERAPY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21518775 ↗
• MalfunctionJan 28, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS APPEARED TO BE FALLING IN BLANKING AT TIMES POSSIBLY TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DEVICE CLASSIFIED TERMINATION OF AT/AF DETECTED EVENT(S). THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 21256449 ↗
• InjuryJan 2, 2025Premature 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 21058857 ↗
• MalfunctionNov 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT'S SPOUSE STATED "PATIENT'S DEVICE IS PART OF A RECALL THAT WAS SEEN ONLINE. ADDITIONALLY, THE PATIENT'S SPOUSE STATED "THE PATIENT IS HAVING LOTS OF SYMPTOMS AND THE DEVICE IS LISTED ON THE WEBSITE AND IT'S EITHER THE DEVICE FAILING OR PATIENT FAILING." THE PATIENT'S SPOUSE WAS INFORMED THE DEVICE DOES NOT HAVE ANY COMMUNICATIONS AND WAS REFERRED TO PHYSICIAN FOR SYMPTOM CONCERNS. 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: Insufficient Information

  MAUDE report 20695517 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND EXPERIENCED SOME REDNESS. 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: Bacteremia; Bacterial Infection; Endocarditis; Erythema; Unspecified Infection

  MAUDE report 20599310 ↗
• MalfunctionOct 10, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PACING BELOW THE LOWER PROGRAMMED RATE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20419145 ↗
• DeathAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT DEVELOPED GANGRENE IN THEIR LOWER EXTREMITIES. THE PATIENT WAS HOSPITALIZED. UPON HOSPITALIZATION, IT WAS NOTED, THAT THE PATIENT HAD ENDOCARDITIS AND VEGETATION WAS NOTED, ON THE LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. AND THE PATIENT WAS PUT ON HOSPICE. THE PATIENT THEN PASSED AWAY.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 20081989 ↗
• MalfunctionAug 9, 2024Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE NOISE AND SHORT VENTRICULAR INTERVALS WERE NOTED ON THE TRANSMISSION. EXTERNAL ELECTROMAGNETIC INTERFERENCE WAS ALSO NOTED. THE PATIENT WAS ASKED ABOUT THE EPISODES NOTING EMI AND THEY COULD NOT REMEMBER ALL, BUT SUSPECTS THEY WERE USING A HOT TUB DURING ONE OF THE EPISODES. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). 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 19953152 ↗
• InjuryJul 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THERE WAS BRADYCARDIA TO 30, WHICH WAS BELOW THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE, AND LOW PRESSURES. THE CRT-D WAS EXPLANTED AND REPLACED TWO AND A HALF WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 19679668 ↗
• InjuryJun 25, 2024Mechanical Problem; Damaged Thread; Mechanical Problem; Damaged Thread

  IT WAS REPORTED THAT DURING A GENERATOR CHANGEOUT PROCEDURE, THE SETSCREW WAS STRIPPED AND COULD NOT BE TURNED TO REMOVE A LEAD PIN. THE PROCEDURE WAS ABANDONED AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 19611002 ↗
• MalfunctionMay 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EMITTED AN ALERT TONE AND MAY HAVE BEEN MALFUNCTIONING. THE CRT-D 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 19366126 ↗
• InjuryFeb 23, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO SYNCOPE.  IT WAS NOTED THAT THE PATIENT HEART RATE WAS IN THE THIRTIES AND FORTIES WHICH IS LOWER THAN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE.  IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD CHRONICALLY LOW R-WAVES THAT HAVE DROPPED BY OVER HALF.  THE DEVICE AND LEAD REMAIN IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 18769381 ↗
• MalfunctionJan 26, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS INITIALLY SEEN DUE TO CHEST PAIN AND A TINGLING SENSATION IN THEIR FACE. THE PATIENT WAS DIAGNOSED WITH BELL'S PALSY AND AN ELECTROLYTE ABNORMALITY AND SIGNIFICANT HYPOKALEMIA. THE CHEST PAIN RESOLVED WITH CORRECTION OF THE ELECTROLYTE ABNORMALITY.

  Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions; Paresthesia

  MAUDE report 18592001 ↗
• InjuryJan 3, 2024Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FEATURE DESIGNED TO WITHHOLD INAPPROPRIATE VENTRICULAR DETECTION IF THE RHYTHM DISPLAYS CHARACTERISTICS OF AN SUPRA VENTRICULAR TACHYCARDIA (SVT) ORIGIN MAY NOT HAVE PROVIDED APPROPRIATE DISCRIMINATION FOR THE PATIENT'S EPISODE OF VENTRICULAR TACHYCARDIA (VT). A PROGRAMMING CHANGE WAS MADE TO THE WAVEFORM COLLECTION METHOD AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18439894 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO SEPTICEMIA. A TEMPORARY RIGHT VENTRICULAR (RV) LEAD WAS PLACED AND CONNECTED TO AN EXTERNAL GENERATOR UNTIL A NEW SYSTEM COULD BE PLACED. BLOOD CULTURES GREW STAPHYLOCOCCUS EPIDERMIDIS. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED. A NEW CRT-D SYSTEM WAS IMPLANTED APPROXIMATELY SEVEN WEEKS LATER.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 18340183 ↗
• MalfunctionOct 6, 2023Electromagnetic Interference; Protective Measures Problem; Electromagnetic Interference; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) A LEAD INTEGRITY ALERT (LIA) TRIGGERED THAT APPEARED TO BE ISOLATED TO ELECTROMAGNETIC INTERFERENCE. THE PATIENT DENIED ANY SURGICAL PROCEDURE AND HAD NO RECOLLECTION OF ACTIVITY DURING THE DAYS THAT THE EMI OCCURRED. THE CRT-D 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 17890354 ↗
• InjurySep 18, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT COMPLAINED OF SHORTNESS OF BREATH AND INDICATED THE DEVICE KEEPS ALARMING.  IT WAS FURTHER REPORTED THAT THE COMPETITOR RIGHT VENTRICULAR (RV) LEAD WAS NOTED WITH HIGH PACING THRESHOLD AND UNDERSENSING. THE CRT-D WAS UNABLE TO BE INTERROGATED, AND IT WAS ASSUMED THE BATTERY DEPLETED, END OF SERVICE (EOS). THE CRT-D WAS EXPLANTED AND REPLACED DUE TO EOS. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT EXPERIENCED LIGHTHEADEDNESS, AND LEG SWELLING. THE PATIENT HAS NOT SEEN THE PHYSICIAN GREATER THAN FIVE YEARS AND NOT TAKING PRESCRIPTIONS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Dyspnea; Swelling/ Edema

  MAUDE report 17769978 ↗
• InjuryJul 21, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. 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 17371907 ↗