Compia MRI CRT-D SureScanRecalls & reported problems across all models

We found 4 models of Compia MRI CRT-D SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2017 and Jul 18, 2024 — classified as 1 death, 29 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (8 reports).

3 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Compia MRI CRT-D SureScan recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 10, 2023Open, 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-1769-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. Feb 3, 2021Open, 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 ↗

3. Dec 19, 2017Terminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0583-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported Compia MRI CRT-D SureScan problems

Compia MRI CRT-D SureScan models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Compia MRI™ CRT-D SureScan™ DTMC1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls11 reports
• Compia MRI™ CRT-D SureScan™ DTMC1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death22 reports
• Compia MRI™ CRT-D SureScan™ DTMC1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall12 reports
• Compia MRI™ CRT-D SureScan™ DTMC1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 report

Recent Compia MRI CRT-D SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH-VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS A RESULT OF ELECTROMAGNETIC INTERFERENCE FROM CAUTERY DURING A SURGICAL PROCEDURE. IT WAS ALSO NOTED THAT DURING THIS PROCEDURE, THERE WAS AN ALERT FOR HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. 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 19773868 ↗
• InjuryJun 19, 2024Failure to Deliver Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING AND HIGH VOLTAGE THERAPY FROM THE CARDIAC R ESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT)-ATRIAL FIBRILLATION (AF) THAT THE DEVICE DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE CRT-D ALSO POSSIBLY INAPPROPRIATELY WITHHELD THERAPY DUE TO THE SVT-AF DISCRIMINATOR. THE  RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING ON STORED ELECTROGRAMS (EGM) THAT RESULTED IN POSSIBLE INAPPROPRIATE PACING OR FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s); Tachycardia

  MAUDE report 19568822 ↗
• MalfunctionJun 10, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A GRAY BAR INDICATING BATTERY VOLTAGE BELOW INDICATION FOR IMPLANT. THE DEVICE WAS NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19497983 ↗
• InjuryFeb 29, 2024Premature 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 18810819 ↗
• InjuryNov 20, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18173703 ↗
• InjuryOct 19, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED INAPPROPRIATE SHOCKS FOR A SINUS ATRIAL RATE DETECTED AS VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE PATIENT MAY HAVE EXPERIENCED SYNCOPE. 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 17969703 ↗
• DeathOct 18, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE INDICATED THAT MULTIPLE SHORT CIRCUIT PROTECTION EPISODES WERE TRIGGERED. DURING THREE EPISODES OF VENTRICULAR FIBRILLATION (VF), THE DEVICE PROVIDED LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY. FOR TWO OF THE EPISODES, THE ARRHYTHMIA APPEARED TO HAVE SELF-TERMINATED. THE THIRD EPISODE WAS IN PROGRESS AT THE TIME OF DATA TRANSMISSION HOWEVER IT WAS LATER IDENTIFIED THAT THE PATIENT IS DECEASED AND DIED ON THE DATE OF TRANSMISSION.

  Patient problems: Arrhythmia; Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 17959556 ↗
• InjuryJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) A POCKET EROSION WITH THE DEVICE EXPOSED WAS NOTED.  A HOLE APPROXIMATELY THREE BY THREE CENTIMETERS WAS OBSERVED AT DISTAL LOWER PORTION OF THE POCKET WITH EDGE OF THE CRT-D VISIBLE.  THE CRT-D WAS EXPLANTED, THE LEADS WERE CAPPED AND, REMAIN IN THE PATIENT.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 17322440 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR MANAGEMENT OF HEART FAILURE, FLUID ACCUMULATION AND LOW BLOOD PRESSURE. THE PATIENT WAS ALSO DIAGNOSED WITH ACUTE KIDNEY INJURY.  THE PATIENT WAS STARTED ON DIURETICS AND BLOOD PRESSURE SUPPORT MEDICATION. DURING THEIR STAY, THE PATIENT HAD A STREPTOCOCCUS AGALACTIAE BACTERIAL INFECTION IN THEIR BLOOD, LIKELY CONTRIBUTING TO THE LOW BLOOD PRESSURE. THE PATIENT WAS STARTED ON INTRAVENOUS ANTIBIOTICS AND WAS HOSPITALIZED FOR APPROXIMATELY TEN DAYS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension; Renal Failure

  MAUDE report 17188111 ↗
• MalfunctionJun 12, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS MOVING AROUND AS THEY GOT OLDER. THE PATIENT STATED THAT THEY COULD FEEL IT WHEN LYING DOWN AND DESCRIBED IT AS ALMOST BEING FLIPPED ON ITS SIDE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 17107867 ↗
• InjuryJun 2, 2023Premature Discharge of Battery; Appropriate Device Problem Term/Code Not Available; Premature Discharge of Battery; Appropriate Device Problem Term/Code Not Available

  IT WAS LATER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNEXPECTED BATTERY DEPLETION DUE TO HIGH THRESHOLDS ON A COMPETITOR LEFT VENTRICULAR (LV) LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052590 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT SITE. THE DEVICE WAS EXPLANTED AND REPLACED APPROXIMATELY TWO AND A HALF MONTHS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 16724755 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. DURING REMOVAL OF THE LEFT VENTRICULAR (LV) LEAD, THE TIP BROKE OFF IN THE CORONARY SINUS AND WAS ABANDONED. 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 16343487 ↗
• InjuryJan 24, 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 POCKET EROSION AND INFECTION. ADDITIONALLY, OCCASIONAL T-WAVE OVERSENSING (TWOS) HAS BEEN OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. A TEMPORARY IMPLANTABLE PULSE GENERATOR (IPG) AND RIGHT VENTRICULAR (RV) LEAD WAS USED UNTIL A LEADLESS PACEMAKER WAS IMPLANTED 4 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 16237479 ↗
• InjuryJan 19, 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 REMOVED DUE TO EROSION DUE TO POCKET INFECTION. THE INFECTION REPORTEDLY STEMMED FROM A GENERATOR CHANGE APPROXIMATELY SIX MONTHS PRIOR. THE PATIENT HAD BEEN ON LONG TERM ANTIBIOTICS IN AN EFFORT TO RESOLVE THE ISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 16204414 ↗

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