Compia MRI™ CRT-D SureScan™ DTMC1D1 (UDI 00643169837706)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169837706), received between Oct 30, 2018 and Jun 19, 2024 — classified as 1 death, 15 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (4 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.

Recalls naming this device

1. 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-1769-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 23, 2022Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE SHOWED THAT SHORT CIRCUIT PROTECTION OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY ON THE SECOND AND THIRD SHOCK RELATED TO THE EPISODE, AND IT WAS NOTED THAT THE SHOCKS WERE NOT SUCCESSFUL AT TERMINATING THE EPISODE. IT WAS ALSO NOTED THAT THE LV LEAD LOW PACING IMPEDANCE OCCURRED FOLLOWING HIGH VOLTAGE THERAPY. THE DEVICE WAS LATER EXPLANTED AND REPLACED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 15851903 ↗
• InjuryJun 22, 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 EXTRACTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14777100 ↗
• MalfunctionMar 23, 2022Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED BY THE REMOTE MONITOR. 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 13862560 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11991364 ↗
• MalfunctionFeb 22, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LOWER THAN EXPECTED LONGEVITY WITH FASTER THAN WE ANTICIPATE BATTERY DRAIN. 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 11358949 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Sepsis

  MAUDE report 11194281 ↗
• InjurySep 11, 2020Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation; Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO ELECTROMAGNETIC INTERFERENCE. NOISE CHARACTERISTIC OF SIXTY HERTZ WAS VISIBLE ON TWO ELECTROGRAM CHANNELS. IT WAS NOTED THAT AT THE TIME OF THE INAPPROPRIATE HIGH VOLTAGE THERAPY THE PATIENT WAS WORKING IN THE YARD USING A MANUAL SHOVEL AND CLIPPERS. THERE WAS NO OBVIOUS SOURCE OF ELECTRICITY IN THE VICINITY OF WHERE THE PATIENT WAS WORKING AND THE EVENT COULD NOT BE REPRODUCED. 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 10523184 ↗
• InjuryJul 24, 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) WAS EXPLANTED DUE TO POCKET EROSION AND INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 10320603 ↗
• MalfunctionJan 13, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE TWO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) EXHIBITED BATTERY LONGEVITY ESTIMATES THAT DID NOT MEET INDICATIONS FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT EITHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9582827 ↗
• MalfunctionJan 13, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE TWO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) EXHIBITED BATTERY LONGEVITY ESTIMATES THAT DID NOT MEET INDICATIONS FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT EITHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9582822 ↗
• MalfunctionJan 7, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A BATTERY VOLTAGE THAT DID NOT MEET INDICATIONS FOR IMPLANT. NO ATTEMPT WAS MADE TO IMPLANT THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9558126 ↗
• InjuryJul 25, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PHYSICIAN PERFORMED A POCKET REVISION TO SEW THE DEVICE DOWN AS AN EFFORT TO REDUCE MOVEMENT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8829232 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REQUIRED A HEMATOMA EVACUATION APPROXIMATELY TWO WEEKS POST-CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 8674902 ↗
• InjuryMay 31, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE BEEN INAPPROPRIATELY SHOCKED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR AN ATRIAL ARRHYTHMIA WITH CONCURRENT FAST VENTRICULAR TACHYCARDIA. RIGHT VENTRICULAR (RV) LEAD OVERSENSING AND SHORT VENTRICULAR INTERVALS WERE ALSO NOTED UPON DEVICE INTERROGATION. THE PATIENT HAD REPORTEDLY BEEN SYNCOPAL DURING THE TIME OF THESE EVENTS. THE CRT-D AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 8659116 ↗
• InjuryMay 24, 2019Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED VENTRICULAR PAUSES LOWER THAN THE LOWER PROGRAMMED RATE. A VENTRICULAR ELECTROGRAM REVEALED VENTRICULAR EVENTS NOT BEING SENSED. THE PHYSICIAN NOTED RELIABILITY CONCERNS WITH THE DEVICE. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8640559 ↗
• MalfunctionOct 30, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SCREW WAS TIGHTENED DOWN, BUT LEAD WAS NOT INSERTED ALL THE WAY. LEAD WAS ABLE TO BE PULLED OUT BUT WHEN THE DOCTOR TRIED TO LOOSEN SETSCREW IT WOULD NOT TURN. THE DEVICE WAS ATTEMPTED AND NOT USED. ANOTHER DEVICE WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8020552 ↗