Revo MRI™ SureScan™ RVDR01 (UDI 00613994614742)Recalls & reported problems

Summary

The FDA's MAUDE database contains 721 adverse event reports that list this exact device (DI 00613994614742), received between Feb 9, 2013 and Aug 11, 2026 — classified as 4 deaths, 445 injuries, 272 malfunctions.

The most frequently reported specific device problem is “Reset Problem” (142 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 721 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208838 ↗
• MalfunctionJul 10, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25778440 ↗
• MalfunctionMay 29, 2026Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING DURING AT/AF STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND MISCLASSIFICATION OF EPISODE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED SPIKES SEEN WITHIN THE QRS COMPLEX ON TELEMETRY. THE SYSTEM 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 25329213 ↗
• InjuryMar 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE WHEN THEIR IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED DUE TO NORMAL END OF SERVICE (EOS). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 24625547 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS "BULGES OUT", THUS REQUIRING IT TO BE EXPLANTED AND REPLACED. 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

  MAUDE report 24188177 ↗
• InjuryNov 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT END OF SERVICE (EOS). THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 23656006 ↗
• InjurySep 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED END OF SERVICE (EOS);AND WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22992362 ↗
• MalfunctionAug 27, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF CAPTURE NOTED ON EXTERNAL TELEMETRY, WITH PATIENT HEART RATE INTO THE FORTIES. IT WAS FOUND THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED END OF SERVICE (EOS). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED A VARIATION AND AN INCREASE IN LEAD IMPEDANCES NOTED ON LEAD TRENDS AND ATRIAL CAPTURE COULD NOT BE CONFIRMED. THE IPG WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22903361 ↗
• InjuryAug 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) 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 22826547 ↗
• InjuryMay 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND WAS EXPLANTED AND REPLACED WITH A CARDIAC RE SYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AS AN UPGRADE.

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

  MAUDE report 22112648 ↗
• MalfunctionMar 28, 2025Inappropriate or Unexpected Reset; Reset Problem; Inappropriate or Unexpected Reset; Reset Problem

  IT WAS REPORTED THAT DURING A DEVICE CHECK A MESSAGE CAME UP ON THE "POP-UP WINDOW" BUT THE HEALTHCARE PROFESSIONAL HIT CLEAR AND DID NOT READ EVERYTHING IN THE POP-UP WINDOW. IT WAS REPORTED THAT THERE WAS POTENTIAL FOR A DEVICE RESET. THE IMPLANTABLE PULSE GENERATOR (IPG) 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 21718056 ↗
• InjuryJan 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED NON-PROPHYLACTICALLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272146 ↗
• InjuryJan 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND LIGHTHEADEDNESS. PATIENT STATED THAT THERE WAS A DELAY WITH THE IMPLANTABLE PULSE GENERATOR (IPG) TO RESPOND WHILE THEY DO EXERCISE. THE PATIENT WAS NOT HAPPY WITH THE DEVICE. THE IPG WAS EXPLANTED AND REPLACED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Dyspnea

  MAUDE report 21216509 ↗
• InjuryJan 20, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A POWER ON RESET (POR). IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUTPUTS. THE IPG AND RV 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 21189959 ↗
• InjuryJan 20, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT AN ELECTRICAL RESET OCCURRED ON THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS NOTED THAT THE IPG WAS AT END OF SERVICE (EOS). THE IPG 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 21189888 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE PARTIALLY REMOVED, WITH THE REMAINING PART BEING CAPPED. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19748108 ↗
• InjuryJul 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED CHEST PAIN, VERY BAD HEADACHES, LOW BLOOD PRESSURE, EAR PAIN AND THEY FAINTED ON THEIR FLOOR. THE PATIENT NOTED THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING AND WAS DEAD. THE IPG WAS REMOVED AND REPLACED. FOLLOWING THE IMPLANTATION OF THE REPLACEMENT IPG THE PATIENT EXPERIENCED BLACKING OUT REPEATEDLY AND REDNESS AT THE INCISION SITE. THE PATIENT ALSO NOTED THEIR PACING LEAD WAS NOT WORKING FULLY. THE REPLACEMENT IPG AND THE PACING LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Ear Pain; Headache; Syncope/Fainting

  MAUDE report 19711688 ↗
• InjuryJul 3, 2024Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE LOWER RATE AND WAS UNABLE TO BE INTERROGATED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA, LIGHTHEADEDNESS AND FATIGUE. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19664361 ↗
• InjuryMay 20, 2024Battery Problem; Appropriate Device Problem Term/Code Not Available; Battery Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY ENDED UP IN HOSPITAL FOR ATRIAL FIBRILLATION (AF). THE IPG WAS EXPLANTED AND REPLACED. THE PATIENT ALSO EXPERIENCED ATRIAL FIBRILLATION (AF) WITH THEIR NEW IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 19350430 ↗
• MalfunctionMay 8, 2024Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED BIT FLIP RESULTING IN FULL RESET. THE IPG 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 19268351 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT END OF SERVICE (EOS). THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 19268314 ↗
• InjuryApr 18, 2024Battery Problem; Battery Problem

  THE PATIENT  REPORTED THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) BATTERY WAS DEAD. THE IPG 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 19133856 ↗
• MalfunctionFeb 1, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING. IT WAS REPORTED THAT THE OVERSENSING ON THE RA LEAD AND THE RV LEAD APPEARED TO BE NON-PHYSIOLOGIC. IT WAS FURTHER REPORTED THAT POSSIBLE ELECTROMAGNETIC INTERFERENCE WAS NOTED ON THE IMPLANTABLE PULSE GENERATOR (IPG) ON EPISODE ELECTROGRAMS (EGM). THIS COINCIDED WITH THE PATIENT RECEIVING AN ORTHOPEDIC SURGICAL PROCEDURE. THE SUBSEQUENT AVAILABLE ELECTROGRAMS (EGM) SHOW APPROPRIATE SENSING. THE IPG SYSTEM 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 18622040 ↗
• MalfunctionJan 30, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR HEART RATE IN THIRTIES VIA APPLE WATCH. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE PROGRAMMED LOWER RATE. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18607256 ↗
• InjuryJan 19, 2024Pacing Problem; Battery Problem; Pacing Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS, CHEST DISCOMFORT AND ARRHYTHMIA. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) ALONG WITH SUSPECTED HIGH AND INAPPROPRIATE PACING. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 18541884 ↗