Evera MRI™ XT DR SureScan™ DDMB1D1 (UDI 00643169929197)Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 00643169929197), received between Oct 9, 2017 and Aug 14, 2026 — classified as 3 deaths, 94 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (50 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-0585-2018 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Electromagnetic Interference; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254076 ↗
• InjuryJul 13, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE MAY HAVE DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE THERAPY TO DETECTED VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS DISCUSSED THAT THE WAVELET SCORES WERE WELL BELOW THE THRESHOLD AND THE POST-VENTRICULAR ATRIAL BLANKING (PVAB) PROGRAMMING CAUSED ATRIAL EVENTS TO NOT BE SENSED. 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 25801240 ↗
• InjuryJun 25, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD UNDERSENSING WAS OBSERVED WITH NO IMPACT TO OVERALL DEVICE FUNCTION AND FAR FIELD R-WAVE (FFRW) OVERSENSING WAS OBSERVED FROM THE RIGHT ATRIAL (RA) LEAD TRIGGERING INAPPROPRIATE MODE SWITCH. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY HAVE PROVIDED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR AN SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). ADDITIONALLY THE ICD MAY HAVE DELAYED THERAPY FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE RA LEAD, RV LEAD AND ICD 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 25629918 ↗
• InjuryJan 6, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THERAPY WAS INAPPROPRIATELY WITHHELD FOR FAST VENTRICULAR TACHYCARDIA (FVT) THAT THE IMPLANTABLE CARDIOVERTER D EFIBRILLATOR (ICD) DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT)/ SINUS TACHYCARDIA. IT WAS ALSO NOTED THAT THE PATIENT'S HEART RATE WAS IN THE 20'S. THE PATIENT WAS PROGRAMMED TO A LOWER RATE OF 60BPM. ATROPINE WAS GIVEN AND THE PATIENT'S HEART RATE INCREASED INTO THE 50'S. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 23980217 ↗
• MalfunctionNov 17, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR A DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD 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 23573818 ↗
• InjuryNov 10, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AT TIMES AND THE PATIENT HAD CHRONIC LOW P WAVES. THE RA LEAD REMAINS IN USE. THE ICD WAS LATER EXPLANTED AND REPLACED AFTER REACHING NORMAL RECOMMENDED REPLACEMENT TIME (RRT). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23514023 ↗
• InjuryOct 29, 2025Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED THERAPY FOR DEVICE-DETECTED VENTRICULAR FIBRILLATION (VF). HOWEVER, A REVIEW OF THE EPISODE DATA AND STORED ELECTROGRAMS (EGMS) SUGGESTS THAT THE THERAPY MAY HAVE BEEN INAPPROPRIATELY DELIVERED DURING AN ONGOING ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR)¿SPECIFICALLY SUPRAVENTRICULAR TACHYCARDIA/ATRIAL TACHYCARDIA-ATRIAL FIBRILLATION (SVT/AT-AF)¿RATHER THAN TRUE VF. THERAPY WAS INITIALLY WITHHELD DUE TO WAVELET DISCRIMINATION BUT WAS SUBSEQUENTLY DELIVERED AFTER THE DEVICE DETECTED VF. BOTH THE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE NOTED TO HAVE HIGH THRESHOLDS. THE ICD AND LEADS 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 23415681 ↗
• MalfunctionSep 5, 2025Protective Measures Problem; Appropriate Device Problem Term/Code Not Available; Protective Measures Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR "MACHINE WENT OFF", AND THEIR DOCTOR TOLD THEM THERE IS A LEAK AND THEY MAY REPLACE IT. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 22982422 ↗
• InjuryApr 29, 2025Failure to Charge; Delayed Charge Time; Battery Problem; Failure to Charge; Delayed Charge Time; Battery Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT IS IN HOSPICE CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930347 ↗
• InjuryApr 21, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD INAPPROPRIATELY WITHHELD THERAPY DURING THE PATIENT'S VENTRICULAR TACHYCARDIA (VT), THAT WAS DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD WAS EXPLANTED AND REPLACED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21873839 ↗
• InjuryFeb 24, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) AND THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED RARE OVERSENSING ON STORED ELECTROGRAMS (EGM). IN ADDITION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. THE DEVICE AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 21446420 ↗
• InjuryFeb 18, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH CHEST PAIN. THE REMOTE TRANSMISSION SHOWED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND CAPTURE ON PACED BEATS FOLLOWING THERAPY COULD NOT BE CONFIRMED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR A DETECTED VENTRICULAR FIBRILLATION (VF) EPISODE. IT WAS NOTED THAT ATRIAL FIBRILLATION (AF) WAS IN PROGRESS AT THE TIME OF THE THERAPY. THE ICD AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Shock from Patient Lead(s)

  MAUDE report 21401537 ↗
• MalfunctionJan 16, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A LEAD INTEGRITY ALERT (LIA) ON THE RIGHT VENTRICULAR (RV) CHANNEL DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH-RATE NON-SUSTAINED (HRNS) EPISODES. HRNS EPISODES SHOWED OVERSENSING ON BOTH THE RIGHT ATRIAL (RA) AND RV CHANNELS DUE TO SUSPECTED EXTERNAL INTERFERENCE. 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 21171712 ↗
• MalfunctionDec 27, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT HAS A LONG HISTORY OF MAGNET INTERACTIONS, HOWEVER THE PATIENT CLAIMED THEY WERE "NEVER AROUND A MAGNET AND HAS NEVER BEEN AROUND ONE". THE PATIENT ALSO STATED THE ICD WAS "NOT WORKING PROPERLY AND THERE IS SOMETHING WRONG WITH [THE ICD]". THE ICD 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 21026731 ↗
• InjuryOct 1, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). THE ICD 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 20345666 ↗
• DeathSep 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SHORTNESS OF BREATH AND DEVELOPED OROPHARYNGEAL BLEEDING. THE PATIENT WAS BROUGHT TO THE EMERGENCY DEPARTMENT VIA AMBULANCE. THE PATIENT WAS EVALUATED AND TREATED FOR HYPOTENSION AND POSSIBLE SEPSIS WITH FLUIDS, MEDICATIONS, AND OXYGEN. DUE TO THE PATIENT'S COMPLEX MEDICAL HISTORY INCLUDING TREATMENT FOR OROPHARYNGEAL CANCER AND CONSULTATION WITH MEDICAL CARE TEAM THE PATIENT ELECTED TO PURSUE COMFORT CARE AND PASSED AWAY. THE PATIENT'S CAUSE OF DEATH WAS PROVIDED AS SEVERE HYPOTENSION LIKELY DUE TO BLOOD LOSS ANEMIA, DIURETICS, POSSIBLE SEPSIS, AND HYPOXIC RESPIRATORY FAILURE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Dyspnea; Low Blood Pressure/ Hypotension; Sepsis

  MAUDE report 20219525 ↗
• InjuryAug 22, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY INAPPROPRIATELY DELIVERED A SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED THAT THE PATIENT HEARD A "POOF NOISE" AND THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. THE ICD AND RALEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Shock from Patient Lead(s)

  MAUDE report 20044273 ↗
• InjuryAug 20, 2024Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Electrical /Electronic Property Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT POTENTIALLY RECEIVED INAPPROPRIATE THERAPY CONSISTING OF ANTI-TACHYCARDIA PACING THERAPY AND A SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT) OR SINUS TACHYCARDIA. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 20005815 ↗
• InjuryJul 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT PRIOR TO RV LEAD REPLACEMENT, THE PATIENT HAD INDICATED THAT THEIR DEVICE WAS ALERTING. THE PATIENT LATER REPORTED THAT PRIOR TO THE RV LEAD BEING REPLACED, THEY HAD UNDERGONE A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE AND "IT TRIGGERED DEFIBRILLATION" WHICH IS WHY THEY HAD TO GET A NEW DEFIBRILLATOR ON THE RIGHT SIDE OF THEIR BODY, AND THAT THE PREVIOUS LEADS WERE ABANDONED ON THE LEFT SIDE OF THEIR BODY. THE PATIENT INDICATED THAT THEIR DOCTOR STATED "THAT LEAD MAY HAVE LEAKED", AND "THEY COULDN'T REPLACE THE LEAD, SO THEY REMOVED THE DEFIBRILLATOR AND PLACED A NEW DEVICE". FINALLY, THE PATIENT REPORTED THAT THEY WERE "STILL VERY, VERY SORE AFTER THE IMPLANT". NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 19652080 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT EXPERIENCED AN INFECTION. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19636907 ↗
• InjuryJun 11, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD INAPPROPRIATE WITHHOLDING OF THERAPY BY THE ATRIAL FIBRILLATION (AF)/ATRIAL FLUTTER DISCRIMINATOR AS THE DEVICE HAD DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) FOR WHAT WAS SUSPECTED TO BE VENTRICULAR FIBRILLATION (VF). ADDITIONALLY, IT WAS NOTED THAT THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD CAUSING THE MISCLASSIFICATION OF VENTRICULAR TACHYCARDIA (VT). THE ICD AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ventricular Fibrillation

  MAUDE report 19510951 ↗
• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO DEVICE POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 19316063 ↗
• InjuryApr 11, 2024Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER THE RIGHT VENTRICULAR (RV) LEAD DELIVERED INAPPROPRIATE SHOCKS. THE LEAD HAD A CONFIRMED LOW VOLTAGE FRACTURE AND EXHIBITED HIGH THRESHOLDS. IN ADDITION, THE LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND PACING IMPEDANCE VARIATION AS WELL AS TRIGGERED ALERTS FOR UNDEFINED HIGH SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE, NOISE OVERSENSING, AND UNDEFINED HIGH PACING IMPEDANCE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AT END OF SERVICE (EOS) AND EXHIBITED A LONGER THAN EXPECTED CHARGE TIME AND TRIGGERED A CHARGE CIRCUIT TIMEOUT. THE ICD AND LEAD WERE PROGRAMMED OFF DUE TO THE INAPPROPRIATE SHOCKS. THE ICD AND RV LEAD REMAIN 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 19088767 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. VEGETATION/GROWTH WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19019347 ↗
• MalfunctionMar 25, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED ATRIAL FLUTTER WITH RAPID VENTRICULAR RESPONSE. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE INTERMITTENTLY T-WAVE OVERSENSING (TWOS). THE ICD AND LEAD 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 18968561 ↗