Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ (UDI 00643169543386)Recalls & reported problems

Summary

The FDA's MAUDE database contains 648 adverse event reports that list this exact device (DI 00643169543386), received between Dec 9, 2016 and May 19, 2026 — classified as 18 deaths, 421 injuries, 209 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (119 reports).

4 FDA recall records 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. Feb 3, 2021Class IOpen, 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 ↗

2. 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 ↗

3. Apr 12, 2017Class IITerminated

   An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.

   Z-2117-2017 · Root cause: Software design · Recall details · FDA record ↗

4. Dec 9, 2016Class IITerminated

   During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.

   Z-0962-2017 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 648 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Failure to Interrogate; Battery Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218738 ↗
• MalfunctionMay 18, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED BY THE PATIENTS REPRESENTATIVE THAT THE PATIENT WENT IN FOR AN MAGNETIC RESONANCE IMAGING (MRI) AND FOUND OUT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS DEAD. 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 25205832 ↗
• InjuryDec 9, 2025Unable to Obtain Readings; Device Sensing Problem; Unable to Obtain Readings; Device Sensing Problem

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL (HCP) PROVIDER THAT THERE WERE TRUE VENTRICULAR TACHYCARDIA (VT) EPISODES CAPTURED ON TELEMETRY, HOWEVER, THE DEVICE DID NOT RECORD ANY OF THE EPISODES. A TRANSMISSION WAS SENT DUE TO THE PATIENT EXPERIENCING SYNCOPE.THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) STATUS, AND WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting; Tachycardia

  MAUDE report 23758559 ↗
• InjuryNov 7, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO SYNCOPE WITH FALL. IT WAS NOTED THAT THE PATIENT MAY HAVE RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). SEVERAL DAYS LATER, THE CRT-D WAS EX PLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Shock from Patient Lead(s); Syncope/Fainting

  MAUDE report 23498424 ↗
• MalfunctionNov 4, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A REMOTE MONITOR READER POSITION ERROR OCCURRED WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RESULTING IN THE MONITOR NOT CONNECTING AND NO TELEMETRY WITH MYCARELINK. TROUBLESHOOTING STEPS INCLUDED ADJUSTING THE POSITION OF THE READER FOR PLACEMENT ERRORS, POWER CYCLING THE MONITOR, AND REMOVING ANY INTERFERENCE WITHIN SIX FEET. THE PATIENT WAS REFERRED TO THE CLINIC. 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 23472013 ↗
• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET APPROXIMATELY FOUR WEEKS AFTER IMPLANT. AN AREA OF DEHISCENCE THAT MEASURED APPROXIMATELY ONE CENTIMETER WAS NOTED. THE AREA WAS CLEANED AND IMPREGNATED WITH ANTIBIOTIC OINTMENT. APPROXIMATELY FOUR WEEKS THEREAFTER THE PATIENTS SPOUSE REPORTED A SMALL AMOUNT OF WHITE EXUDATE FROM THE WOUND, BUT NO ERYTHEMA OR TENDERNESS. THE AREA WAS CLEANED AND STERI-STRIPS AND DRESSING WERE PACED. ORAL ANTIBIOTICS WERE ADMINISTERED. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Wound Dehiscence

  MAUDE report 23441817 ↗
• MalfunctionSep 30, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED POST OPERATIVE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRTD 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 23183569 ↗
• MalfunctionMay 29, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT AN INCREASE IN RIGHT VENTRICULAR (RV) LEAD DEFIBRILLATION IMPEDANCE AND LEFT VENTRICULAR (LV) LEAD PACING IMPEDANCE WAS NOTED ON LEAD TRENDS. IN ADDITION, THE CLINICIAN REPORTED CONCERN REGARDING CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FUNCTION AND STATED THE DEVICE WAS PACING ON THE T WAVE. IT WAS ALSO NOTED THAT THE CRT-D WAS DETECTING VENTRICULAR TACHYCARDIA (VT) AS SUPRA VENTRICULAR TACHYCARDIA (SVT). THE RV LEAD, LV LEAD AND CRT-D 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 22111354 ↗
• DeathApr 24, 2025Device Alarm System; Failure to Interrogate; Pacing Problem; Device Alarm System; Failure to Interrogate; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE CLINICIAN WAS WAITING TO PERFORM A DEVICE CHANGE-OUT AS THE PATIENT WAS BEING ASSESS FOR LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. HOWEVER, IT WAS NOTED THAT PATIENT LATER PASSED AWAY DUE TO HEART FAILURE BEFORE THEY COULD RECEIVE A REPLACEMENT OR LVAD.

  Patient problems: Heart Failure/Congestive Heart Failure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905905 ↗
• InjuryApr 1, 2025Failure 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 CONFIRMED, VIA FOLLOW UP, THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE.

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

  MAUDE report 21749193 ↗
• InjuryMar 25, 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) AND LEADS WERE "MALPOSITIONED" AND IMPENDING SKIN PERFORATION WAS PRESENT. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO BEING AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE NEW DEVICE AND CHRONIC LEADS WERE PLACED IN A MORE SUBMUSCULAR POCKET. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 21688244 ↗
• DeathFeb 4, 2025Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED BY THE PATIENTS FAMILY MEMBER THAT THE PATIENT IS DECEASED. THE FAMILY MEMBER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS CONTINUOUSLY EMITTING AN ALERT TONE AND EVERY TIME THE PATIENT RAISED THEIR HAND A FLAT LINE FOUND WHICH IS INCREDIBLY DISTRACTING WHILE THE PATIENT WAS IN HOSPICE. THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21308864 ↗
• MalfunctionJan 31, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD MIGRATED. 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 21288982 ↗
• InjuryJan 24, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AND RIGHT ATRIAL (RA) LEAD UNDERSENSING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. IT WAS ALSO REPORTED THAT THE RA LEAD HAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE RA LEAD REMAINS IN USE. THE RA LEAD SENSITIVITY WAS ADJUSTED DOWN TO PROMOTE BETTER SENSING OF ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 21229977 ↗
• InjuryJan 21, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING A ROUTINE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGE OUT PROCEDURE, IT WAS NOTED THAT THE CRT-D HAD SHIFTED TO THE PATIENT¿S LEFT AXILLA CAUSING THE PATIENT DISCOMFORT. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 21200161 ↗
• InjuryJan 13, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA THAT WAS BELOW THE LOWER PROGRAMMED PACING RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PATIENT WAS TREATED WITH ATROPINE PRIOR TO BEING ADMITTED TO THE EMERGENCY DEPARTMENT. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21145299 ↗
• MalfunctionNov 26, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY A NURSE THAT THE PATIENT HAD HEART RATES TO THIRTY-FOUR BEATS PER MINUTE AND PACING ON PREMATURE VENTRICULAR CONTRACTIONS (PVC). IT WAS NOTED THAT THE HEART RATES WERE BELOW THE PROGRAMMED LOWER RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20789354 ↗
• MalfunctionNov 12, 2024Loss of Data; Loss of Data

  IT WAS REPORTED THAT THE PATIENT INFORMATION PART OF THE INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF DATA. IT WAS NOTED THAT THE QUESTIONS WERE AT THE TIME OF THE POST RADIATION INTERROGATION. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS WORKING FINE AND THAT THE QUESTIONS MARKS WERE LIKELY DUE TO THE RADIATION TREATMENT. 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 20667761 ↗
• MalfunctionOct 25, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION AND A CHANGE IN HEART RHYTHM AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD NON-SPECIFICALLY FAILED. THE DEVICE REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 20531564 ↗
• InjuryOct 18, 2024Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH-RATE NON-SUSTAINED EPISODES AND SHORT V-V INTERVALS. IT WAS NOTED THAT THE RV LEAD EXHIBITED UNDERSENSING AND OVERSENSING. IT WAS ALSO NOTED THAT THE RV LEAD HAD AN IMPEDANCE WARNING DUE TO LOW IMPEDANCE MEASUREMENTS. THERE APPEARS TO BE UNDERSENSING OF ONGOING VENTRICULAR FIBRILLATION (VF) ALONG WITH POSSIBLE CHEST COMPRESSIONS AND EXTERNAL SHOCK SHOWN ON THE ELECTROGRAMS (EGM). IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY WITHHELD THERAPY DUE TO THE DEVICE SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR FEATURE THAT CAN HELP PREVENT THE INAPPROPRIATE DETECTION OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AS A VENTRICULAR TACHYCARDIA (VT) BY EVALUATING THE STABILITY OF VENTRICULAR INTERVALS. IT WAS NOTED THAT THE DEVICE CLASSIFIED THE EPISODE AS SVT, BUT IT WAS SUSPECTED TO BE TRUE VENTRICULAR FIBRILLATION (VF) RESULTING IN A DELAY IN THERAPY. IT WAS ALSO NOTED THAT THE HEALTHCARE PROFESSIONAL FELT THE PATIENT WAS NOT SHOCKED APPROPRIATELY. EVENTUALLY CHEST COMPRESSIONS AND EXTERNAL SHOCKS WAS NEEDE

  Patient problems: Ventricular Fibrillation

  MAUDE report 20487298 ↗
• MalfunctionSep 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED, VIA FOLLOW UP, THAT THE DEVICE WAS FUNCTIONING PROPERLY.

  Patient problems: Fall

  MAUDE report 20291916 ↗
• InjurySep 10, 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 POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY AND HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). 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 20183821 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, AND THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. A TEMPORARY LEAD WAS USED WITH AN EXTERNAL PACING DEVICE FOR SEVERAL DAYS BEFORE A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Drug Resistant Bacterial Infection

  MAUDE report 19943466 ↗
• InjuryJul 26, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN THRESHOLDS ON THE LV2 TO RV COIL WITH SOME POSSIBLE PHRENIC NERVE STIMULATION. THE LV PACE POLARITY WAS ADJUSTED TO THE LV1 TO RV COIL AND FURTHER DEVICE TESTING SHOWED IMPROVED THRESHOLDS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD INTERMITTENT DIAPHRAGMATIC STIMULATION SINCE THE LAST VISIT. THE DEVICE WAS REPROGRAMMED TO ADJUST THE POLARITY, AMPLITUDE AND LEAD PULSE WIDTH. IT WAS FURTHER REPORTED THAT WHEN THE LV LEAD WAS REPROGRAMMED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY LIFE DECREASED. IT WAS NOTED AT SUBSEQUENT OFFICE VISITS THERE WAS NO FURTHER STIMULATION, BUT THE BATTERY CONTINUED TO DEPLETE. THE CRT-D WAS EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839339 ↗
• InjuryJul 8, 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 POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING AND HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR FAST VENTRICULAR TACHYCARDIA (FVT). THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT CAUSED POSSIBLE FALSE DETECTION OF VENTRICULAR ARRYTHMIAS. THE CRT-D WAS EXPLANTED AND REPLACED THE SAME DAY. THE RA LEAD 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 19696694 ↗