Revo MRI™ SureScan™ RVDR01 (UDI 00643169493407)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00643169493407), received between Feb 9, 2017 and Apr 23, 2026 — classified as 2 deaths, 18 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Reset Problem” (8 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND PRE SYNCOPE. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENISNG AND NOISE. IT WAS FURTHER REPORTED THAT ELECTROMAGNETIC INTERFERENCE (EMI) WAS NOTED ON THE IMPLANTABLE PULSE GENERATOR (IPG). THE LEAD AND IPG 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 24966891 ↗
• MalfunctionMar 25, 2026Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAS "MOVED" AND IS "CLOSER TO BEING UNDER THEIR ARM THAN WHERE IT WAS ORIGINALLY." 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 24685053 ↗
• MalfunctionSep 8, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THEY WERE UNABLE TO CONFIRM CAPTURE ON ATRIAL LEAD ON CURRENT ELECTROGRAMS (EGM). 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 22990771 ↗
• InjuryJul 9, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) THE IPG WAS EXPLANTED AND RE PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455747 ↗
• InjuryJul 3, 2025Premature Discharge of Battery; Premature Discharge of Battery

  THE PATIENT REPORTED THAT THEY WERE TOLD BY THERE DOCTOR THAT THEIR "DEVICE IS ALREADY LOW IN BATTERY".  THE IMPLANTABLE PULSE GENERATOR (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 22392576 ↗
• MalfunctionMay 28, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY FEEL THEIR IMPLANTABLE PULSE GENERATOR (IPG) PULLING OUT AND IT HURTS. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 22095230 ↗
• MalfunctionApr 26, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN, SHORTNESS OF BREATH. IT WAS NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE PROGRAMMED LOWER RATE AND THE PATIENT EXPERIENCED BRADYCARDIA. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AT TIMES. THE IPG SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Chest Pain; Dyspnea

  MAUDE report 19191106 ↗
• MalfunctionMar 5, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEART RATE LOWER THAN THE LOWER PROGRAMMED PACING RATE OF THE IMPLANTABLE PULSE GENERATOR (IPG), WHICH WAS SET TO SIXTY BEATS PER MINUTE. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 18835898 ↗
• InjuryDec 4, 2023Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT THAT THE REMOTE MONITOR WAS NOT GETTING ANY TELEMETRY WHEN ATTEMPTING TO SEARCH FOR THE IMPLANTABLE PULSE GENERATOR (IPG). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL AND PATIENT WAS REFERRED TO DEVICE CLINIC TO HAVE IMPLANT CHECKED WITH THE PROGRAMMER. THE MONITOR AND IPG 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 18254744 ↗
• DeathJul 31, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA IN THE FORTIES WHICH IS BELOW THE IMPLANTABLE PULSE GENERATOR (IPG) LOWER RATE. THE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED A POSITION CHECK FAILURE. THE IPG AND LEAD REMAIN IN USE. IT WAS ALSO NOTED THAT THE PATIENT HAS SINCE PASSED AWAY.

  Patient problems: Bradycardia

  MAUDE report 17425008 ↗
• InjuryJun 13, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED TO THE CLINIC WITH CRITICALLY LOW BATTERY VOLTAGES. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS SUSPECTED WITH PREMATURE BATTERY DEPLETION. 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 17116261 ↗
• MalfunctionMay 15, 2023Unable to Obtain Readings; Device-Device Incompatibility; Reset Problem; Unable to Obtain Readings; Device-Device Incompatibility; Reset Problem

  IT WAS REPORTED THAT THE PROGRAMMER DISPLAYED A DIAGNOSTIC MESSAGE INDICATING THAT A FULL POWER ON RESET (POR) OCCURRED IN THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO A BIT FLIP. DIAGNOSTIC DATA WAS NOTED TO BE MISSING. THE IPG WAS PACING APPROPRIATELY AT THE PROGRAMMED PACING MODE AND RATE. IT WAS NOTED THAT A MAGNETIC RESONANCE IMAGING (MRI) HAD RECENTLY BEEN UNDERWENT. THE IPG AND PROGRAMMER 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 16928952 ↗
• MalfunctionMay 9, 2023Communication or Transmission Problem; Communication or Transmission Problem

  COMPLAINT: THE REMOTE MONITOR WAS NOT WORKING. TROUBLESHOOTING: IT WAS CONFIRMED THAT THE PATIENT WAS NOT ENROLLED. THE PATIENT WAS REFERRED TO THE CLINIC. OUTCOME: OTHER IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NO TELEMETRY. 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 16893561 ↗
• InjuryMar 31, 2023Patient-Device Incompatibility

  REPORTER CALLED WITH COMPLAINT ABOUT HER SURESCAN PACEMAKER. APPROXIMATELY A YEAR-AND-A-HALF AFTER IT WAS IMPLANTED ((B)(6) 2013), SHE STARTED HAVING SYNCOPIZED EPISODES. BEFORE HER PACEMAKER IMPLANT, SHE NEVER HAD ANY ISSUES WITH HAVING SYCOPE. PRESENTLY, SHE IS EXPERIENCING SYNCOPE THAT IS CYCLIC AND RANGING EVERY THREE TO FOUR WEEKS, UP TO 10 TIMES PER DAY. HER PACEMAKER IS SET AT 80BPM BUT WILL GO DOWN TO 60BPM AT TIMES. REPORTER STATES THAT THESE EPISODES ARE NOT RELATED TO HER ACTIVITIES, DRIVING, FLYING, ETC. SHE HAS ATTEMPTED NUMEROUS TIMES TO CONTACT HER PHYSICIAN ABOUT THIS TO NO AVAIL. THEY CONSISTENTLY TELL HER "NOTHING IS WRONG". AFTER NINE YEARS, SHE HAS NOT BEEN ABLE TO GET HELP/ASSISTANCE IN THIS MATTER. REPORTER STATES THAT THESE SYNCOPE INCIDENCES HAVE CAUSED SEVERE DEPRESSION.

  Patient problems: Depression; Syncope/Fainting

  MAUDE report 16664759 ↗
• InjuryNov 18, 2022Unable to Obtain Readings; Loss of Data; Reset Problem; Unable to Obtain Readings; Loss of Data; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD A DEVICE RESET AND IT WAS CONFIRMED AS A BIT FLIP. THE IPG WAS REPROGRAMMED AND 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 15823109 ↗
• MalfunctionOct 4, 2022Missing Test Results; Missing Test Results

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY VOLTAGE WAS UNAVAILABLE DUE TO A BIT FLIP. 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 15535170 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ENDOCARDITIS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED. NO FURTHER PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 15281790 ↗
• MalfunctionApr 26, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY FELT LIKE THEY WERE GOING TO PASS OUT WHEN THEY WERE STANDING NEAR AN ELECTRICAL BOX WHERE THERE WAS A BROKEN WIRE AND THAT THEIR DEVICE STARTED MALFUNCTIONING. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 14203018 ↗
• MalfunctionAug 31, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS AND HAS CONCERNS ABOUT THE IMPLANTABLE PULSE GENERATOR (IPG) SINCE REPROGRAMMING. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 12390970 ↗
• MalfunctionJul 5, 2021Loss of Data; Reset Problem; Loss of Data; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A POWER-ON-RESET (POR) AND A BIT FLIP. 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 12116230 ↗
• InjuryMar 4, 2021Reset Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED BACK TO NORMAL SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11409913 ↗
• InjuryFeb 8, 2021Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FULL ELECTRICAL POWER ON RESET (POR). THE IPG WAS REPROGRAMMED AND 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 11291974 ↗
• MalfunctionNov 25, 2020Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND OVERSENSING. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD EPISODES OF INVALID DATA. THE RA LEAD AND IPG 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 10904447 ↗
• DeathAug 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT IS DECEASED. THE REPORTER QUERIED WHY THEY WEREN'T INFORMED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) "WAS NOT WORKING". FOLLOW UP WAS INITIATED TO DETERMINE THE CAUSE OF DEATH HOWEVER NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Death

  MAUDE report 10384815 ↗
• InjuryJul 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Syncope

  MAUDE report 10275569 ↗