Advisa DR MRI™ SureScan® A2DR01 (UDI 00763000059613)Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 00763000059613), received between Feb 5, 2018 and Sep 9, 2026 — classified as 4 deaths, 104 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (41 reports).

16 other recalls cover devices cleared under the same FDA submission (P980035); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Failure to Capture; Pacing Problem

  It was reported that the Implantable Pulse Generator (IPG) exhibited beats in the blanking period on stored episode resulting in ina ppropriate atrial pacing with atrial loss of capture. It was also reported that the Right Atrial (RA) lead exhibited undersensing on stored episode resulting in inappropriate pacing with atrial loss of capture. The IPG and RA 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 50689014 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pocket erosion. The Implantable Pulse Generator (IPG), Right Ventricular (RV) lead, and Right Atrial (RA) lead were explanted and another RV lead was capped. The system was replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Pocket Erosion

  MAUDE report 50476499 ↗
• InjuryFeb 6, 2026Missing Test Results

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PROGRAMMED TO MAGNETIC RESONANCE IMAGING (MRI) SURESCAN MODE FOR AN E XTENDED PERIOD OF TIME BY USER ERROR AND WAS UNABLE TO PROVIDE AN ELECTIVE REPLACEMENT INDICATOR (ERI)/RECOMMENDED REPLACEMENT TIME (RRT) UPDATE. 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 24277704 ↗
• MalfunctionJan 14, 2026Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED TELEMETRY ISSUES. THE IPG SYSTEM REMAINS IN USE. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068723 ↗
• MalfunctionJan 14, 2026Pacing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED ATRIAL EVENTS FALLING IN BLANKING PERIOD WHICH RESULTED IN DEVICE CLASSIFIED TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENTS AND UNNECESSARY ATRIAL PACING AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AT/AF STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. LOW AMPLITUDE P WAVES WERE NOTED. THE IPG AND RA 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 24065362 ↗
• InjuryDec 23, 2025Pacing Problem; Data Problem; Pacing Problem; Data Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND A HEART RATE BELOW THE LOWER PROGRAMMED RATE. IT WAS NOTED THAT THE DEVICE CLOCK ON THE IMPLANTABLE PULSE GENERATOR (IPG) WAS INCORRECT. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 23875425 ↗
• MalfunctionDec 3, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND LOSS OF CAPTURE. IT IS ALSO REPORTED THAT THERE WAS SUSPECTED ABNORMAL DEVICE FUNCTION AS PATIENT WAS HAVING HEART RATES IN THE FIFTIES. THE LEAD REMAINS IN USE, THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED AS RECOMMENDED REPLACEMENT TIME (RRT) WAS TRIGGERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23702573 ↗
• InjurySep 5, 2025Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE PATIENT FELL WHICH RESULTED IN A BRAIN BLEED. ITS REPORTED THAT THERE IS AN INTEGRITY/INSULATION ISSUE AND A SUSPECTED SENSING ISSUE ON THE RIGHT ATRIAL (RA) LEAD. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE AND OVER SENSING WHICH LED TO PACER INHIBITION. THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED OVER SENSING AND THERE WAS A SIX SECOND PAUSE ON TELEMETRY. MIRROR IMAGE OVER SENSING WAS ALSO SUSPECTED. THE RV LEAD WAS CAPPED AND REPLACED, THE IPG WAS REMOVED AND REPLACED WITH A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), AND THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Non specific EKG/ECG Changes; Syncope/Fainting

  MAUDE report 22976762 ↗
• MalfunctionSep 2, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DEVICE APPEARS TO BE INTERMITTENTLY UNDERSENSING ON RIGHT VENTRICULAR (RV) LEAD RESULTING TO INTERMITTENT INAPPROPRIATE RV PACING. THE LEAD WAS ALSO EXHIBITED HIGH THRESHOLD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). IT WAS FURTHER REPORTED THAT IT WAS SUSPECTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING WITH THE FAST RATES SEEN ON TELEMETRY DUE TO NO PACING AT TIME OF ELEVATED RATES.

  Patient problems: Tachycardia

  MAUDE report 22936020 ↗
• MalfunctionAug 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S RELATIVE THAT THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) SCAN WHERE THE DEVICE WAS "TURNED OFF" AND WAS NOT "TURNED BACK ON" FOR APPROXIMATELY FIVE MONTHS. SHE SAID THEY HAD A SCAN IN THE HOSPITAL TODAY AND IS ASKING IF THE DEVICE WAS EVER "TURNED BACK ON". 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 22712124 ↗
• InjuryJul 17, 2025Adverse 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 IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND THE LEADS WERE CAPPED. THE IPG SYSTEM WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22529168 ↗
• InjuryJun 20, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT A RECORDED EPISODE SHOWED SUDDEN ONSET ARRHYTHMIA THAT BEGAN WITH AN EARLY INTRINSIC VENTRICULAR BEAT FOLLOWED BY INTRINSIC ATRIAL COMPLEXES. THE TERMINATION WAS SUDDEN AND ENDED WITH AN INTRINSIC P WAVE. THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS 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

  MAUDE report 22295895 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ELEVATED HEART RATE AND NAUSEA. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPGROMMAED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nausea; Tachycardia

  MAUDE report 22097010 ↗
• InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA. THE ORGANISM WAS IDENTIFIED TO BE STAPHYLOCOCCUS EPIDERMIDIS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22095696 ↗
• InjuryJan 9, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE ON STORED ELECTROGRAMS (EGM). THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 21110744 ↗
• MalfunctionJan 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THERE WAS NO ISSUE WITH THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE IPG HAD NOT REACHED THE RECOMMENDED REPLACEMENT TIME (RRT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090960 ↗
• InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTEREMIA INFECTION AND VEGETATION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IPG SYSTEM. THE LEAD LESS IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 20639277 ↗
• InjuryNov 1, 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. IT WAS NOTED IT WAS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS BACTEREMIA. THE PATIENT WAS TREATED WITH INTRAVENOUS (IV) ANTIBIOTICS. THE IPG SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; Bacterial Infection; High Blood Pressure/ Hypertension; Respiratory Failure; Septic Shock; Unspecified Infection

  MAUDE report 20586842 ↗
• InjuryOct 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HIGH TEMPERATURE AND CHEST PAIN THAT WERE NOT RESOLVED BY NITRO. THE PATIENT HAD AN EPISODE AND HAD CARDIOPULMONARY RESUSCITATION, WAS INTUBATED AND PLACED ON A VENTILATOR. THE PATIENT WAS PLACED IN INTENSIVE CARE UNIT (ICU) AND THE RIGHT LUNG WAS FULL OF INFECTION A COUPLE OF PROCEDURES WERE DONE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest; Chest Pain; Fever; Unspecified Infection

  MAUDE report 20506179 ↗
• MalfunctionOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE IMPLANTABLE PULSE GENERATOR (IPG) 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 20462045 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BROUGHT INTO THE HOSPITAL FOR A POCKET REVISION. IT WAS THEN THEY DISCOVERED THAT THE PATIENT SUFFERED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. THE RIGHT ATRIAL (RA) AND THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND WILL BE EXTRACTED AT ANOTHER FACILITY . NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20446818 ↗
• InjuryOct 10, 2024Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE AND PRESYNCOPE. UNEXPLAINED LOSS OF CAPTURE WAS NOTED AND THE IPG EXHIBITED A PACING ISSUE. THE IPG WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness; Presyncope; Syncope/Fainting; Tachycardia

  MAUDE report 20415971 ↗
• MalfunctionSep 23, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING WITH HIGH V-V INTERVAL SENSING INTEGRITY COUNTER (SIC) CO UNT. IT WAS ALSO SUSPECTED THAT THERE MAY BE A LOOSE SETSCREW CAUSING THE OVERSENSING. BOTH THE RV LEAD AND IMPLANTABLE PULSE GENERATOR (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 20279301 ↗
• InjurySep 17, 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 WITH VEGETATION ON THE RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD, MITRAL VALVE AND AORTIC VALVE. THE ORGANISM WAS IDENTIFIED AS STREPTOCOCCUS SANGUINIS. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 20235853 ↗
• MalfunctionApr 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT THOUGHT THE IMPLANTABLE PULSE GENERATOR (IPG) STOPPED WORKING. 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 19141581 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980035. One submission often covers many models, so check the product and lot details in each record.

• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-1924-2025 · Apr 29, 2025 · Open, Classified
  Azure S DR MRI SureScan, Product number W3DR01
• Z-2507-2020 · Jun 4, 2020 · Open, Classified
  Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01
• Z-2508-2020 · Jun 4, 2020 · Open, Classified
  Azure S DR MRI, Model Number W3DR01
• Z-2510-2020 · Jun 4, 2020 · Open, Classified
  Azure S SR MRI, Model Number W3SR01
• Z-2509-2020 · Jun 4, 2020 · Open, Classified
  Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01
• Z-0811-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
• Z-0806-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Mo
• Z-0809-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
• Z-0808-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
• Z-0807-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number
• Z-0810-2019 · Jan 17, 2019 · Open, Classified
  Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
• Z-2120-2011 · Apr 4, 2011 · Terminated
  Medtronic, Kappa 600 KDR600,KDR601,KDR603,KDR606,KDR651,KDR653 The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Wit
• Z-1440-2010 · Feb 11, 2010 · Terminated
  Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects,

…and 1 more.