Attain Performa S MRI SureScanRecalls & reported problems across all models

We found 2 models of Attain Performa S MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,825 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 30, 2026 — classified as 38 deaths, 1,737 injuries, 1,050 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (656 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 Attain Performa S MRI SureScan problems

Attain Performa S MRI SureScan models

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

• Attain Performa™ S MRI SureScan™ 459888

  permanent pacemaker Electrode
  33 deaths2,374 reports
• Attain Performa™ S MRI SureScan™ 459878

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  5 deaths451 reports

Recent Attain Performa S MRI SureScan adverse event reports

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

• InjurySep 30, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952547 ↗
• InjurySep 30, 2026Intermittent Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951877 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to an infection resulting in discomfort, erosion, redness, swelling and wound dehiscence. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erosion; Erythema; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 50934517 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923749 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50891966 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that three months post Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant, the patient experienced a device pocket infection, discomfort, pain, purulent discharge, redness, and swelling. The CRT-D system was explanted and then replaced six days later. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 50888930 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to a mobile echogenic mass/vegetation attached to the Right Atrial (RA) lead. It was noted that the patient also experienced discomfort. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Medical device site infection

  MAUDE report 50882162 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50828438 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection

  MAUDE report 50781043 ↗
• MalfunctionSep 15, 2026Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  It was reported that during an implant procedure a guidewire was unable to smoothly track through the Left Ventricular (LV) lead. When the wire was pulled back the lead came with it. The LV lead was removed and replaced with a new lead. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50777543 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 50762408 ↗
• InjurySep 14, 2026Extracardiac stimulation

  It was reported that three transmissions were missing current electrograms (EGM). The Cardiac Resynchronization Therapy Pacemaker (CRT-P) remains in use. It was further noted that the patient experienced diaphragmatic stimulation and the Left Ventricular (LV) lead was reprogrammed. No further patient complications have been reported as a result of this event.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50754068 ↗
• MalfunctionSep 10, 2026Capturing Problem; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722193 ↗
• MalfunctionSep 8, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679164 ↗
• MalfunctionSep 8, 2026Low impedance; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited high capture thresholds and low pacing impedance. The lead 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 50674959 ↗

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