Attain Ability Straight 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
- 89
- Deaths reported
- 1
- Injuries reported
- 57
- Recalls
- 0
We found 4 models of Attain Ability Straight MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 89 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 3, 2026 — classified as 1 death, 57 injuries, 31 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (29 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 Straight MRI SureScan problems
Device problems
- High Capture Threshold29
- Adverse Event Without Identified Device or Use Problem26
- Failure to Capture15
- Device Dislodged or Dislocated12
- Capturing Problem7
- Impedance Problem6
- Appropriate Device Problem Term/Code Not Available5
- Intermittent Capture4
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Known Impact Or Consequence To Patient18
- Unspecified Infection9
- Muscle Stimulation6
- Undesired Nerve Stimulation6
- Device Overstimulation of Tissue5
- No Consequences Or Impact To Patient3
- Bacteremia2
Attain Ability Straight MRI SureScan models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Attain Ability™ Straight MRI SureScan™ 439688permanent pacemaker Electrode1 death46 reports
- Attain Ability™ Straight MRI SureScan™ 439688permanent pacemaker Electrode23 reports
- Attain Ability™ Straight MRI SureScan™ 439678permanent pacemaker Electrode14 reports
- Attain Ability™ Straight MRI SureScan™ 439678permanent pacemaker Electrode6 reports
Recent Attain Ability 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.
InjurySep 3, 2026Extracardiac stimulation
It was reported that the Left Ventricular (LV) lead patient was feeling a thumping in their abdomen while laying on their left side. The patient was stated to have underlying rhythm of Complete Heart Block. Reprogramming was performed and the thumping in the patient abdomen ceased. The patient is a participant in a clinical study. The lead remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Device Overstimulation of Tissue; Heart Block
MAUDE report 50588565 ↗MalfunctionFeb 27, 2026Capturing Problem; Impedance Problem; High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A SPIKE IN CAPTURE THRESHOLD AND HIGH THRESHOLDS. IT WAS NOTED THAT THERE WAS A JUMP IN LV LEAD IMPEDANCE AS WELL. 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 24474483 ↗MalfunctionFeb 25, 2026High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS ABOVE THE PROGRAMMED AMPLITUDE. 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 24444267 ↗InjuryNov 10, 2025Failure to Capture; Over-Sensing; Impedance Problem; High Capture Threshold; Failure to Capture; Over-Sensing; Impedance Problem; High Capture Threshold
IT WAS REPORTED THAT LEAD PLACED IN THE ANTERIOR CARDIAC VEIN AND PLUGGED INTO THE RIGHT VENTRICULAR (RV) LEAD PACE SENSE PORTION OF THE DEVICE HEADER EXHIBITED A LOSS OF CAPTURE, A RISE IN PACING IMPEDANCE, ELEVATED THRESHOLDS AND OVERSENSING NOTED ON THE CURRENT ELECTROGRAM (EGM). THE LEAD WAS REPROGRAMMED AND 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 23512496 ↗InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD REMAINS IN USE. IT WAS ALSO NOTED THAT THE PATIENT HAD EXPERIENCED EXTRACARDIAC STIMULATION FROM THE PACING LEAD IMPLANTED IN THE MIDDLE CARDIAC VEIN. THE LEAD WAS REPROGRAMMED SUBTHRESHOLD AND REMAINS IN SITU. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Overstimulation of Tissue; No Clinical Signs, Symptoms or Conditions
MAUDE report 23369212 ↗MalfunctionAug 18, 2025Intermittent Capture; Intermittent Capture
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. THE LEAD REMAINS IN USE. NO PATIENT COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22835292 ↗InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION WITH REDNESS, SWELLING, AND PURULENT DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema
MAUDE report 22666756 ↗MalfunctionMar 17, 2025High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED 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 21621159 ↗MalfunctionMar 7, 2025Failure to Capture; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Failure to Capture; Adverse Event Without Identified Device or Use Problem; High Capture Threshold
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO NOTED THAT THE LV LEAD EXHIBITED HIGH THRESHOLDS AND OCCASIONAL LOSS OF CAPTURE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Undesired Nerve Stimulation
MAUDE report 21551937 ↗InjuryFeb 19, 2025High Capture Threshold; High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LV LEAD WAS EXPLANTED AND REPLACED WITH A LEFT BUNDLE BRANCH PACING LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21415413 ↗MalfunctionSep 30, 2024Impedance Problem; Impedance Problem
IT WAS REPORTED THAT THE MOBILE APPLICATION USED FOR MAGNETIC RESONANCE IMAGING (MRI) ACCESSIBILITY GENERATED A DIAGNOSTIC MESSAGE INDICATING THAT LEAD IMPEDANCE WAS OUT OF RANGE WHEN ATTEMPTING TO PROGRAM THE DEVICE TO MRI MODE. THE LEFT VENTRICULAR (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 20335256 ↗InjurySep 20, 2024Break; Break
IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE OUTER INSULATION OF THE LEFT VENTRICULAR (LV) LEAD WAS DAMAGED WITH ELECT ROCAUTERY AFTER OPENING THE POCKET, EXPOSING THE LEADS AND RESECTING THE SCAR TISSUE. THE LEAD WAS TESTED THOROUGHLY WITH NO ELECTRICAL ABNORMALITIES. THE PHYSICIAN DECIDED TO SUTURE A LEAD ANCHORING SLEEVE OVER THE SMALL AREA WHERE THE INSULATION WAS DAMAGED. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN INCREASE TO HIGH THRESHOLD MEASUREMENT. THE REASON FOR THE RV LEAD CHRONIC CAPTURE THRESHOLD INCREASE IS UNKNOWN. BOTH 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 20267982 ↗MalfunctionAug 27, 2024Failure to Capture; High impedance; Low impedance; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Failure to Capture; High impedance; Low impedance; Adverse Event Without Identified Device or Use Problem; High Capture Threshold
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN WARNING FOR HIGH UNDEFINED IMPEDANCE. THE LV EXHIBITED POSSIBLE LOSS OF CAPTURE AND THE THRESHOLDS WERE HIGHER THAN THE PROGRAMMED OUTPUT. IT WAS NOTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LV LEAD IN SOME PACING VECTORS. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Undesired Nerve Stimulation
MAUDE report 20079374 ↗MalfunctionAug 12, 2024Over-Sensing; Under-Sensing; Over-Sensing; Under-Sensing
IT WAS FURTHER REPORTED THAT THE PATIENT HAD A DEVICE CHECK CHECK/OFFICE VISIT. NO ACTION/INTERVENTION WAS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19964684 ↗InjuryAug 6, 2024Adverse 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 APPROXIMATELY FIVE MONTHS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZA TION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WITH AN ABSORBABLE ENVELOPE. PURULENT DISCHARGE/PUS AND REDNESS WERE NOTED. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Erythema; Purulent Discharge; Unspecified Infection
MAUDE report 19920877 ↗
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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