Attain Performa Straight 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
- 1,925
- Deaths reported
- 31
- Injuries reported
- 1,297
- Recalls
- 0
We found 2 models of Attain Performa Straight MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,925 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 30, 2026 — classified as 31 deaths, 1,297 injuries, 597 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (495 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 Straight MRI SureScan problems
Device problems
- Adverse Event Without Identified Device or Use Problem801
- High Capture Threshold495
- Failure to Capture236
- Capturing Problem209
- Device Dislodged or Dislocated156
- High impedance86
- Appropriate Device Problem Term/Code Not Available82
- Low impedance72
Patient problems
- No Clinical Signs, Symptoms or Conditions661
- Unspecified Infection418
- No Known Impact Or Consequence To Patient207
- Undesired Nerve Stimulation147
- Device Overstimulation of Tissue137
- Muscle Stimulation85
- No Consequences Or Impact To Patient46
- Sepsis39
Attain Performa Straight MRI SureScan models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Performa™ Straight MRI SureScan™ 439888Drug eluting permanent left ventricular (lv) pacemaker electrode26 deaths1,595 reports
- Attain Performa™ Straight MRI SureScan™ 439878permanent pacemaker Electrode5 deaths330 reports
Recent Attain Performa Straight 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, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952438 ↗InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936943 ↗MalfunctionSep 25, 2026Capturing Problem
It was reported that the Left Ventricular (LV) lead and Right Ventricular (RV) lead exhibited rising pacing thresholds. The leads re main in use. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899304 ↗MalfunctionSep 25, 2026Capturing Problem
It was reported that the Left Ventricular (LV) lead exhibited rising 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 50897441 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately one month post replacement procedure, the patient developed a pocket infection. It was noted that the patient developed purulent discharge/pus. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and 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 50877091 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced bacteremia. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) and leads were explanted and replaced with a leadless Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia
MAUDE report 50868656 ↗InjurySep 22, 2026Extracardiac stimulation
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50859213 ↗InjurySep 18, 2026Fracture; Capturing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829309 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50827665 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50811601 ↗MalfunctionSep 17, 2026Low impedance
It was reported that the Left Ventricular (LV) lead exhibited 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 50803840 ↗MalfunctionSep 15, 2026High Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited high thresholds. It was also reported that the Right Atrial (RA) lead had position check failure. Both LV and RA 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 50766879 ↗MalfunctionSep 14, 2026Impedance Problem
It was reported that the Right Ventricular (RV) lead exhibited an increase in pacing impedance and possible loss of capture, and the Left Ventricular (LV) lead exhibited an increase in pacing impedance. The leads 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 50754905 ↗InjurySep 11, 2026Appropriate Device Problem Term/Code Not Available
It was reported that five months post implant, the Left Ventricular (LV) lead was explanted and replaced for unknown reasons. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736691 ↗MalfunctionSep 10, 2026Intermittent Capture; Pacing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721374 ↗
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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