Attain Performa MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,186
- Deaths reported
- 52
- Injuries reported
- 2,859
- Recalls
- 0
We found 2 models of Attain Performa MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 4,186 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2016 and Sep 30, 2026 — classified as 52 deaths, 2,859 injuries, 1,275 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (868 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
Reports received per month, all models
Most reported Attain Performa MRI SureScan problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,619
- High Capture Threshold868
- Device Dislodged or Dislocated671
- Failure to Capture483
- Capturing Problem303
- Activation, Positioning or Separation Problem214
- High impedance197
- Appropriate Device Problem Term/Code Not Available193
Patient problems
- No Clinical Signs, Symptoms or Conditions1,386
- Unspecified Infection909
- No Known Impact Or Consequence To Patient659
- Undesired Nerve Stimulation266
- Muscle Stimulation236
- Device Overstimulation of Tissue221
- No Consequences Or Impact To Patient118
- Erythema70
Attain Performa MRI SureScan models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Performa™ MRI SureScan™ 429888permanent pacemaker Electrode38 deaths3,377 reports
- Attain Performa™ MRI SureScan™ 429878permanent pacemaker Electrode14 deaths809 reports
Recent Attain Performa 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, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Endocarditis; Unspecified Infection
MAUDE report 50953779 ↗MalfunctionSep 30, 2026Mechanical Problem; Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952730 ↗InjurySep 29, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940893 ↗InjurySep 29, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935486 ↗InjurySep 29, 2026Extracardiac stimulation; High Capture Threshold
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50933210 ↗InjurySep 29, 2026Failure to Capture
Patient problems: Chest Pain; Syncope/Fainting
MAUDE report 50932892 ↗MalfunctionSep 25, 2026Failure to Capture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903701 ↗InjurySep 24, 2026Extracardiac stimulation
It was reported that the Left Ventricular (LV) lead was "turned off since it is giving too much power that the patient can feel it". No further patient complications have been reported as a result of this event.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50885621 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted for an unknown/unspecified reason. A new system was implanted a few days later. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50871925 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that shortly after the Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant, the patient experienced a large hematoma on the left side for which incision and drainage was performed on the left side. It was suspected that subsequently the patient developed infection with weakness, bacteremia, erosion and organism identified as Methicillin sensitive staphylococcus aureus (MSSA). The CRT-D system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Bacterial Infection; Erosion; Muscle Weakness/Atrophy
MAUDE report 50869978 ↗MalfunctionSep 23, 2026High Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited chronic high thresholds. The LV 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 50866040 ↗MalfunctionSep 18, 2026Impedance Problem
It was reported that the Left Ventricular (LV) lead exhibited Out of Range (OOR) impedance measurement. The lead is still in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819273 ↗InjurySep 17, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810089 ↗InjurySep 17, 2026Extracardiac stimulation
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50809104 ↗InjurySep 16, 2026Device Dislodged or Dislocated; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795300 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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