Advisa SR MRI SureScanRecalls & reported problems across all models

We found 2 models of Advisa SR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 246 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Sep 16, 2026 — classified as 17 deaths, 127 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (49 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 SR MRI SureScan problems

Advisa SR MRI SureScan models

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

• Advisa SR MRI™ SureScan™ A3SR01

  Pulse generator, permanent, implantable
  16 deaths230 reports
• Advisa SR MRI™ SureScan® A3SR01

  Implantable pulse generator, pacemaker (non-CRT)
  1 death16 reports

Recent Advisa SR 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 16, 2026Premature Discharge of Battery

  It was reported that the Right Ventricular (RV) lead exhibited high thresholds leading to battery depletion of the Implantable Pulse Generator (IPG). The 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 50787855 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection with discomfort. The Implantable Pulse Generator (IPG) system was explanted a replaced with a Leadless implantable pulse generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50342673 ↗
• MalfunctionJun 4, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE 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 25388144 ↗
• InjuryNov 28, 2025Pacing Problem; Pacing Problem

  IT WAS FURTHER NOTED THAT THE RV LEAD AND IPG WERE EXPLANTED AND REPLACED.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 23670614 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23645757 ↗
• DeathNov 12, 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 LEFT IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23530967 ↗
• MalfunctionSep 4, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENTS REMOTE MONITOR DOES NOT ALLOW THEM TO COMPLETE THERE TRANSMISSION, AND EACH TIME IS ATTEMPTED IT SHOWS ERROR CODE. 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 22962521 ↗
• InjuryAug 29, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS IN A SERIOUS ACCIDENT AND BELIEVED THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING DURING THE ACCIDENT. IT WAS ALSO NOTED THE PATIENT PASSED OUT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22921038 ↗
• DeathAug 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT DIED. IT WAS FURTHER NOTED THAT THE "DEVICE WAS NOT SATISFACTORY AND CONTRIBUTED TO THE PATIENTS PASSING". THE IMPLANTABLE PULSE GENERATOR (IPG) REMAINS IN PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22871379 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION WITH PURULENT DISCHARGE/PUS NOTED. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Purulent Discharge

  MAUDE report 22392604 ↗
• InjuryJan 10, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENTS HUSBAND THAT THE PATIENT EXPERIENCED BRADYCARDIA AND THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS PACING BELOW THE 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 21122275 ↗
• MalfunctionJan 6, 2025Pacing Problem; Pacing Problem

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

  Patient problems: Bradycardia

  MAUDE report 21077712 ↗
• InjuryDec 2, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE AND SYNCOPE. IT WAS ALSO REPORTED THAT THE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE AND WAS DROPPING BEATS. THE LEAD WAS REPROGRAMMED. RISING THRESHOLDS INTERMITTENT LOSS OF CAPTURE WAS STILL NOTED ON THE LEAD.  DURING THE CHANGEOUT PROCEDURE, WHEN THE RV LEAD WAS TESTED, HIGH OUT OF RANGE IMPEDANCE WAS NOTED POSSIBLY DUE TO THE DEVICE EXHIBITING CONNECTOR PORT ISSUES. THE LEAD WAS CAPPED, AND DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole; No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 20818255 ↗
• MalfunctionNov 12, 2024Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT ERROR CODE 3269 APPEARED IN THE APPLICATION INDICATING A BLUETOOTH FAILURE OCCURRED. IT WAS ALSO REPORTED THAT THERE WAS NO TELEMETRY WITH THE IMPLANTABLE PULSE GENERATOR (IPG). TROUBLESHOOTING STEPS WERE TAKEN TO NO AVAIL. REFERRED PATIENT TO THE CLINIC. THE SMART READER AND THE IPG REMAIN IN USE. THE SMART READER APPLICATION 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 20665370 ↗
• MalfunctionOct 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED, THAT THERE WAS A CONCERN THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT WORKING CORRECTLY. 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 20462450 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
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• 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