Advisa DR MRI SureScanRecalls & reported problems across all models

We found 3 models of Advisa DR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 4,238 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2013 and Sep 30, 2026 — classified as 96 deaths, 2,313 injuries, 1,829 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (803 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Advisa DR MRI SureScan problems

Advisa DR MRI SureScan models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Advisa DR MRI™ SureScan® A2DR01

  Pulse generator, permanent, implantable
  51 deaths2,298 reports
• Advisa DR MRI™ SureScan® A2DR01

  Implantable pulse generator, pacemaker (non-CRT)
  41 deaths1,758 reports
• Advisa DR MRI™ SureScan® A2DR01

  Implantable pulse generator, pacemaker (non-CRT)
  4 deaths182 reports

Recent Advisa DR MRI SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Pacing Problem

  It was reported that atrial events were  falling in blanking period. Observed device classified termination of AT/AF detected events and inappropriate atrial pacing.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944120 ↗
• MalfunctionSep 29, 2026Pacing Problem

  The patient reported that after an Magnetic Resonance Imaging (MRI) they felt unwell. They reported that during the MRI there heart was pounding, then after they experienced lightheaded-ness, dizziness, fatigue and heart rates in the forties. The Implantable Pulse Generator (IPG) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Dizziness; Fatigue; Palpitations

  MAUDE report 50932243 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. The Implantable Pulse Generator (IPG) system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50917596 ↗
• MalfunctionSep 28, 2026Pacing Problem

  It was reported that atrial events were falling in blanking period. Observed device classified termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) detected events resulting in inappropriate atrial pacing. 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 50913470 ↗
• MalfunctionSep 24, 2026Pacing Problem

  It was reported that the patient experienced weakness and the Implantable Pulse Generator (IPG) was pacing below the lower set rate. 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 50883354 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection and erosion. A skin ulcer was noted at the pocket site. The Implantable Pulse Generator (IPG) system was removed. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Pocket Erosion; Ulcer

  MAUDE report 50866830 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced endocarditis. The Implantable Pulse Generator (IPG) was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Endocarditis

  MAUDE report 50751043 ↗
• 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 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient felt the pacing and pulsing in their neck and it wakes them up at night. It was also reported that the Right Ventricular (RV) lead exhibited steadily increasing impedance resulting in high impedance causing them to be unable to have Magnetic Resonance Imaging (MRI) scan. Both the Implantable Pulse Generator (IPG) and the RV lead remains in use. No further patient complications have been reported as a result of this event. It was further reported that the RV lead exhibited polarity switch. The RV lead was reprogrammed and the IPG was explanted and replaced.

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

  MAUDE report 50688933 ↗
• InjurySep 7, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50647315 ↗
• MalfunctionSep 4, 2026Pacing Problem

  It was further reported that the IPG did not exhibit a performance issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611223 ↗
• InjurySep 1, 2026Electrical /Electronic Property Problem

  Patient problems: Chest Pain

  MAUDE report 50542949 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection. The Implantable Pulse Generator (IPG) system was explanted with no replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50516520 ↗
• 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 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection. The Implantable Pulse Generator (IPG) was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50403577 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls