Attain Ability MRI SureScanRecalls & reported problems across all models
Medtronic, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 255
- Deaths reported
- 0
- Injuries reported
- 176
- Recalls
- 0
We found 4 models of Attain Ability MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 255 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 30, 2026 — classified as 176 injuries, 79 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (70 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 Ability MRI SureScan problems
Device problems
- Device Dislodged or Dislocated70
- High Capture Threshold68
- Adverse Event Without Identified Device or Use Problem66
- Failure to Capture43
- Appropriate Device Problem Term/Code Not Available17
- Capturing Problem16
- Activation, Positioning or Separation Problem11
- High impedance9
Patient problems
- No Clinical Signs, Symptoms or Conditions80
- No Known Impact Or Consequence To Patient65
- Unspecified Infection32
- Muscle Stimulation21
- Undesired Nerve Stimulation16
- No Consequences Or Impact To Patient11
- Device Overstimulation of Tissue10
- Wound Dehiscence6
Attain Ability MRI SureScan models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Ability™ MRI SureScan™ 419688permanent pacemaker Electrode153 reports
- Attain Ability™ MRI SureScan™ 419688permanent pacemaker Electrode74 reports
- Attain Ability™ MRI SureScan™ 419678Drug eluting permanent left ventricular (lv) pacemaker electrode17 reports
- Attain Ability™ MRI SureScan™ 419678permanent pacemaker Electrode11 reports
Recent Attain Ability 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; Adverse Event Without Identified Device or Use Problem
Patient problems: Non specific EKG/ECG Changes
MAUDE report 50952367 ↗MalfunctionSep 30, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951605 ↗MalfunctionSep 15, 2026High impedance; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779074 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection
MAUDE report 50542996 ↗MalfunctionAug 21, 2026Capturing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50374773 ↗MalfunctionAug 11, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50213504 ↗MalfunctionMay 27, 2026High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND THRESHOLDS GREATER THAN THE PROGRAMMED OUTPUTS. 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 25306323 ↗InjuryMay 14, 2026Extracardiac stimulation
IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT EXPERIENCED "ONE OF THEIR LEADS GOING AGAINST THEIR DIAPHRAGM" AND THAT THEY HAD TROUBLE SLEEPING. THEY REPORTED BEING IN THEIR DOCTOR'S OFFICE FOR ADJUSTMENTS TWICE. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Overstimulation of Tissue; Sleep Dysfunction
MAUDE report 25175896 ↗MalfunctionMay 13, 2026Capturing Problem
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD IMPLANTED IN THE RIGHT VENTRICULAR (RV) PORT EXHIBITED INCREASED THRESHOLDS. 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 25166611 ↗InjuryMay 4, 2026Device Dislodged or Dislocated
IT WAS REPORTED BY THE PATIENT FIANCÉE THAT THE LEFT VENTRICULAR (LV) LEAD MOVED AFTER IMPLANT. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25068370 ↗InjuryApr 9, 2026Under-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO SENSING. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829241 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 24735351 ↗MalfunctionMar 19, 2026Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING IN NON-PHYSIOLOGIC INTERVALS WITH POSSIBLE INHIBITION OF PACING. IT WAS NOTED THAT THE PATIENT EXPERIENCED LIGHTHEADEDNESS. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Dizziness
MAUDE report 24637412 ↗MalfunctionMar 16, 2026High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. 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 24607859 ↗InjuryFeb 12, 2026High impedance
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) PACING IMPEDANCE. NOISE WAS ALSO OBSERVED ON THE RV LEAD AND A LOW VOLTAGE FRACTURE WAS SUSPECTED. THE RV LEAD WAS EXPLANTED AND REPLACED. ADDITIONALLY, DURING THE RV LEAD REPLACEMENT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) PACING IMPEDANCE AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24324457 ↗
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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