Amplia MRI™ CRT-D SureScan™ DTMB1D1 (UDI 00643169837690)Recalls & reported problems
Medtronic, Inc. · CRTD DTMB1D1 AMPLIA MRI US DF1 · Class 3 · Implant
All models of Amplia MRI CRT-D SureScan (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Medtronic Amplia MRI CRT-D is an implantable defibrillator that also paces the heart. Many of the 112 reports describe electrical problems and batteries running down early. Some devices were removed, often after infections. The reports include 57 injuries and 2 deaths. One open recall, started in May 2023, covers a rare chance of weak or no shock energy during high-voltage therapy.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 114
- Deaths reported
- 3
- Injuries reported
- 58
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00643169837690), received between Sep 14, 2018 and Sep 29, 2026 — classified as 3 deaths, 58 injuries, 53 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (33 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.
Reports received per month
Recalls naming this device
- May 10, 2023Class IOpen, Classified
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
Z-1761-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Electrical /Electronic Property Problem33
- Adverse Event Without Identified Device or Use Problem20
- Premature Discharge of Battery19
- Device Sensing Problem9
- Inappropriate/Inadequate Shock/Stimulation6
- Appropriate Device Problem Term/Code Not Available5
- Electromagnetic Interference5
- Mechanical Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- No Patient Involvement19
- Unspecified Infection18
- No Known Impact Or Consequence To Patient13
- Shock from Patient Lead(s)6
- No Consequences Or Impact To Patient5
- Tachycardia5
- Discomfort2
Recent adverse event reports
The 25 most recent of 114 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937443 ↗DeathSep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported by the patients representative that the patient implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) system "had a sepsis infection from "[the]" defibrillator ports" and "there was an infection on the lead from "[the]" defibrillator". The patient¿s representative reported the patient was "put on antibiotics instead of replacing as usually done". The patient expired approximately 8 weeks later.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 50883708 ↗MalfunctionMay 27, 2026Failure to Interrogate
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED. 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 25303451 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A DEVICE POCKET INFECTION WITH DISCOMFORT, REDNESS, AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection
MAUDE report 24874419 ↗InjuryOct 27, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN-CLINIC AND NORMAL DEVICE FUNCTION WAS NOTED. THERE WERE NO CRT-D OR LEAD ISSUES IDENTIFIED AND THE PATIENT SYMPTOMS WERE NOT DEVICE RELATED.
Patient problems: Dizziness; Fall; Headache
MAUDE report 23389900 ↗InjuryJan 30, 2025Premature 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 21279711 ↗InjuryJan 15, 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. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Unspecified Infection
MAUDE report 21159244 ↗InjuryJan 8, 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) WAS EXPLANTED DUE TO EROSION AND INFECTION. THE LEADS WERE CAPPED AND REMAIN USABLE IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Erosion; Unspecified Infection
MAUDE report 21104262 ↗MalfunctionJul 26, 2024Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference
IT WAS REPORTED THAT OVERSENSING CONSISTENT WITH EXTERNAL ELECTROMAGNETIC INTERFERENCE WAS OBSERVED ON THE ATRIAL AND VENTRICULAR ELECTROGRAMS (EGM). THE NOISE WAS NOT BEING SENSED ON THE VENTRICULAR CHANNEL. THE ONLY POTENTIALLY POORLY SHIELDED ITEM THE PATIENT COULD REMEMBER BEING AROUND WAS A FISH TANK. 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 19837502 ↗MalfunctionJul 23, 2024Electromagnetic Interference; Electromagnetic Interference
IT WAS REPORTED THAT AT LEAST TWO EPISODES OF EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI) WITH 60 HZ CYCLICAL PATTERN WERE NOTED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D). NO PROGRAMMING CHANGES WERE MADE AND 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 19804184 ↗InjuryMay 8, 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) SHOULD HAVE PROVIDED HIGH VOLTAGE THERAPY AND THERAPY WAS INAPPROPRIATELY WITHHELD. THE PATIENT WAS IN VENTRICULAR TACHYCARDIA (VT), BUT THE DEVICE CLASSIFIED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Tachycardia
MAUDE report 19266586 ↗InjuryMay 6, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem
IT WAS LATER CONFIRMED THROUGH FOLLOW UP THAT THE SHOCKS WERE INAPPROPRIATELY WITHHELD DUE TO ATRIAL FIBRILLATION (AF) DISCRIMINATION. THE DEVICE WAS REPROGRAMMED.
Patient problems: Tachycardia
MAUDE report 19254901 ↗MalfunctionMar 12, 2024Failure to Interrogate; Failure to Interrogate
IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR ( CRT-D). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. ADVISED TO CONTACT THE DOCTOR TO CHECK THE CRT-D. THE CRT-D AND MONITOR 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 18890659 ↗InjuryNov 6, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED AFTER A PRESUMED VENTRICULAR TACHYCARDIA (VT) STORM. THE CLINICIAN REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT TREATING THE PATIENT'S VT. IT WAS NOTED IN ONE EPISODE THAT THE VT PERSISTED BELOW THE DETECTION RATE POST-ANTI-TACHYCARDIA PACING THERAPY AND CLASSIFICATION OF THE EVENT AS TERMINATED. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Tachycardia
MAUDE report 18073371 ↗InjurySep 11, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIALLY INAPPROPRIATE ANTI-TACHYCARDIA PACING AND A SHOCK FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE WHICH WAS DETECTED BY CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS VENTRICULAR FIBRILLATION (VF). 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 17725767 ↗InjurySep 1, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE BATTERY LONGEVITY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT MEET THE EXPECTATIONS OF THE PHYSICIAN. 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 17673686 ↗InjuryAug 14, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 17539897 ↗DeathJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 18 DAYS POST ROUTINE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REPLACEMENT, THE PATIENT PASSED AWAY. NO FURTHER DETAILS ARE AVAILABLE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.
Patient problems: Insufficient Information
MAUDE report 17365157 ↗InjuryJul 17, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HISTORY OF HIGH THRESHOLD WITH PROGRAMMED HIGH OUTPUTS. THE LV LEAD WAS CAPPED AND REMAINS IN THE PATIENT. A NEW LV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17336000 ↗InjuryJul 12, 2023Premature 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 17307068 ↗InjuryJun 15, 2023Premature 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 17137181 ↗InjuryJun 8, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem
IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE DEVICE POTENTIALLY INAPPROPRIATELY WITHHELD THERAPY FOR AN SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DURING VENTRICULAR FIBRILLATION (VF). THE CRT-D REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARED TO BE UNDERSENSING THAT WAS NOTED ON STORED ELECTROGRAM (EGM) RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) DETECTION. THE RA LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2023, ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS SEEN BY THE FACILITY APPROXIMATELY THREE WEEKS LATER. THE POTENTIALLY INAPPROPRIATELY WITHHELD THERAPY FOR AN SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE WAS NOT IDENTIFIED. IT WAS INDICATED THAT APPROPRIATE SHOCKS WERE ADMINISTERED FOR VENTRICULAR TACHYCARDIA (VT) STORM. NO ACTION/INTERVENTION WAS PERFORMED.
Patient problems: Tachycardia
MAUDE report 17087763 ↗InjuryMay 19, 2023Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT A COMPETITOR RIGHT ATRIAL (RA) LEAD DISLODGED RESULTING IN HIGH ATRIAL OUTPUT AND PREMATURE BATTERY DEPLETION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 16962483 ↗InjuryApr 21, 2023Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation
IT WAS FURTHER REPORTED THROUGH FOLLOW UP THAT THE SENSING ISSUE WAS DUE TO CAUTERY.
Patient problems: Shock from Patient Lead(s)
MAUDE report 16791557 ↗InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS FURTHER REPORTED CULTURES WERE PERFORMED AND WERE NEGATIVE FOR THE INFECTION, JUST EXPOSED DEVICE THROUGH EROSION. IT WAS ALSO REPORTED THAT THE PATIENT LOST 80 POUNDS.
Patient problems: Pocket Erosion
MAUDE report 16243400 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)4 recalls40 deaths1,639 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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