Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ (UDI 00643169929647)Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00643169929647), received between Oct 6, 2017 and Feb 3, 2026 — classified as 3 deaths, 69 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (13 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-0582-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORT THAT THE PATIENT IS ¿HAVING ISSUES¿ WITH THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IS EXPERIENCING CHEST PAIN AND A RAPID HEARTBEAT. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 24251172 ↗
• MalfunctionJan 27, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING EXPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR A ROUTINE CHANGEOUT, THERE WAS AN ISSUE WITH THE SETSCREW AND WRENCH INTERFACE. THE CRTD WAS SUCCESSFULLY REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193609 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DURING ROUTINE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGE OUT PROCEDURE THE POCKET INCISION HAD A SMALL ESCHAR. A POCKET REVISION TO ELIMINATE THE AREA OF ESCHAR WAS PERFORMED. IT WAS NOTED THAT THE PATIENT HAD A PREVIOUS POCKET INFECTION THAT REQUIRED EXTRACTION WITH A COMPETITOR DEVICE SYSTEM. THE CRT-D WAS SUCCESSFULLY REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Necrosis

  MAUDE report 23803617 ↗
• MalfunctionSep 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT "MY CHEST IS VIBRATING WHERE THE SCAR IS (LOCATED). THE OTHER DAY IT WAS PUFFED UP WHERE THE SCAR IS AND I WENT TO THE EMERGENCY ROOM TWICE AND THEY TOLD ME TO FOLLOW UP WITH THE PHYSICIAN AND MANUFACTURER. I CALLED THE CARDIOLOGIST AND HE IS OUT OF OFFICE UNTIL AFTER LABOR DAY AND THEY CAN SEE ME THEN. IT COMES AND GOES AND LASTS ABOUT TWO SECONDS. CAN'T ANYONE TELL ME IF IT IS DEFECTIVE?" THE PATIENT WAS REFERRED TO THE PHYSICIAN. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016596 ↗
• InjuryJan 17, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS MALFUNCTIONING, SPECIFICALLY THAT THERE WAS A LACK OF ALERTS. 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 21179720 ↗
• MalfunctionJan 15, 2025Battery Problem; Battery Problem

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE BATTERY LIFE ON THE PATIENT¿S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR SEVERAL MONTHS WAS AT SIX MONTHS AND THIS MONTH IT DROPPED TO THREE MONTHS. 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 21158478 ↗
• InjuryNov 13, 2024Pacing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem; Pacing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE FEATURE DESIGNED TO WITHHOLD VENTRICULAR TACHYARRHYTHMIA DETECTION WHEN THERE IS SENSED 1:1 ATRIAL TO VENTRICULAR CONDUCTION OF RHYTHMS THAT EXHIBIT A GRADUAL INCREASE IN RATE INTO THE DETECTION ZONE, INAPPROPRIATELY DELAYED FAST VENTRICULAR TACHYCARDIA (FVT) DETECTION. THE DEVICE DID EVENTUALLY DETECT AND THE ARRYTHMIA TERMINATED AFTER ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPIES WERE PROVIDED. 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: Tachycardia

  MAUDE report 20675011 ↗
• InjurySep 24, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT POSSIBLY RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES THAT WERE DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 20293108 ↗
• InjuryAug 15, 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 (ATP) AND HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED T-WAVE OVERSENSING (TWOS) WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD, HOWEVER, THIS DID NOT RESULT IN INAPPROPRIATE DETECTION. FOLLOW UP CONCLUDED NO INTERVENTION WAS DONE AT THIS TIME. THE DEVICE AND LEAD 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 19996206 ↗
• InjuryJul 22, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO SYNCOPE. AN INTERROGATION WAS REVIEWED AND NOTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR FIBRILLATION (VF). 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); Syncope/Fainting

  MAUDE report 19790757 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPLACED DUE TO SWELLING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling/ Edema

  MAUDE report 19570883 ↗
• InjuryMar 8, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS POSSIBLY INAPPROPRIATELY SHOCKED FOR SINUS TACH THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 18867063 ↗
• InjuryJan 3, 2024Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED SIX SHOCKS DUE TO EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI). 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 18435509 ↗
• InjurySep 21, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVC) THAT CAN CAUSE THE MONITOR TO INCORRECTLY READ THE HEART RATE AS LOWER THAN THE CRT-D MAY BE PROGRAMMED.

  Patient problems: Bradycardia; Non specific EKG/ECG Changes

  MAUDE report 17794191 ↗
• InjurySep 15, 2023Failure 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) POTENTIALLY WITHHELD THERAPY INAPPROPRIATELY FOR THE DETECTION OF VENTRICULAR TACHYCARDIA (VT) THAT WAS CLASSIFIED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) ¿ SINUS TACHYCARDIA.  IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE TO HIGH IMPEDANCE MEASUREMENTS THAT WAS HIGHER THAN THE PROGRAMMED IMPEDANCE THRESHOLD.  IT WAS ALSO NOTED THAT THE LV LEAD HAD AN INCREASE TO HIGH THRESHOLD MEASUREMENTS.  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A DROP IN R-WAVE AMPLITUDE.  THE DEVICE AND LEADS REMAIN IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 17758567 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN EPIDURAL ABSCESS IN THE SPINE AND THE ABSCESS WAS LATER REMOVED. THE INFECTION BECAME SYSTEMIC AND INVOLVED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. IT WAS NOTED THAT THE PATIENT FELT PAIN AND DISCOMFORT, DEVELOPED A FEVER, AND THERE WAS OBSERVED PURULENT DISCHARGE/PUS, SWELLING AND REDNESS. THE CRT-D SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abscess; Bacterial Infection; Discomfort; Erythema; Fever; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 17644090 ↗
• InjuryMar 27, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS IN THE SUPERIOR VENA CAVA (SVC). THE LEAD WAS EXPLANTED AND REPLACED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO THE DISLODGEMENT. REPROGRAMMING WAS PERFORMED AND 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 16621725 ↗
• DeathMar 21, 2023Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT¿S SPOUSE THAT THE PATIENT IS DECEASED. THE PATIENT¿S SPOUSE ALLEGES THAT THE PATIENT¿S DEATH IS DUE TO A DEFECTIVE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THAT ¿NEVER DISPLAYED ERROR MESSAGES SUCH AS RECOMMEND REPLACEMENT, AND FULL BATTERY DEPLETION. YET, THE FACILITY NURSE CONFIRMED THAT THE DEVICE HAD EXTREMELY LOW BATTERY LIFE. A FEW DAYS BEFORE THE PATIENT EXPIRED, THE PATIENT¿S FAMILY MEMBER INQUIRED WITH A CLINICAL REPRESENTATIVE ABOUT THE BATTERY LIFE OF THE CRT-D AT THE TIME, BECAUSE THE DEVICE HAD GONE OFF SO MANY TIMES NEEDLESSLY.¿ THE PATIENT¿S SPOUSE ALLEGES THAT THE ¿CLINICAL REPRESENTATIVE SHARED WITH A FAMILY MEMBER THAT THE BATTERY WAS RIDICULOUSLY LOW.¿ THE PATIENT¿S SPOUSE NOTED THAT PRIOR TO HOSPITALIZATION A REMOTE MONITOR TRANSMISSION WAS REVIEWED BY THE PHYSICIAN AND NO ISSUES WERE IDENTIFIED. THE PATIENT¿S SPOUSE STATED THAT DURING HOSPITALIZATION ¿THE PATIENT WAS GETTING SHOCKED (THERAPY) UNNECESSARILY MAKING THE HEART WEAKER AND WEAKER WITH EVERY SHOCK. THE NIGHT THE PATIENT NEEDED THE DEVICE MOST THE DEVICE DID NOT PERFORM. THE SHOCK THERAPY DIDN¿T HAPPEN. THE DEVICE SHOCKED SO MANY TIMES WHEN IT SHOULDN¿T HAV

  Patient problems: Cardiac Arrest; Nausea; Pain; Tachycardia; Vomiting

  MAUDE report 16585741 ↗
• MalfunctionDec 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A "SYSTEM FUNCTION ABNORMAL." THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973523 ↗
• InjurySep 1, 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) POCKET EROSION. THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM, THE DEVICE POCKET WAS OPENED AND REVISED. THE DEVICE WAS REINSERTED, AND THE POCKET WAS CLOSED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 15343057 ↗
• MalfunctionSep 1, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT ""FELL ILL, COULD NOT BREATHE, AND THEIR BLOOD OXYGEN WAS DOWN TO 78".  IT WAS SUSPECTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Low Oxygen Saturation

  MAUDE report 15337653 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED REDNESS AND PURPLE DISCOLORATION WITH DISCHARGE AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANTED SITE. ORAL ANTIBIOTICS WERE PRESCRIBED AND THE CRT-D REMAINS IN USE. 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; Skin Discoloration; Unspecified Infection

  MAUDE report 15322368 ↗
• InjuryAug 16, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WITHHELD THERAPY FOR A LIKELY EPISODE OF VENTRICULAR TACHYCARDIA (VT) THAT WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 15236849 ↗
• InjuryJul 26, 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 A POSSIBLE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15102404 ↗
• InjuryJul 18, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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 15047626 ↗