Attain Performa™ MRI SureScan™ 429888Recalls & reported problems
Medtronic, Inc. · LEAD 429888 MRI CANT US · Class 3 · Implant
All models of Attain Performa MRI SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Attain Performa MRI lead is an implanted wire that carries electrical pulses between a heart pacemaker and the heart. Its 3,351 reports mostly describe the lead moving out of place, the heart not responding to pacing pulses, and leads being removed and replaced after infection or erosion. The reports include 38 deaths and 2,283 injuries. No recalls name this device. Reports were lower in the most recent year (299) than in the year before (356).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 3,377
- Deaths reported
- 38
- Injuries reported
- 2,299
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,377 adverse event reports that list this exact device (DI 00643169601833), received between Dec 9, 2016 and Sep 30, 2026 — classified as 38 deaths, 2,299 injuries, 1,040 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (691 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,290
- High Capture Threshold691
- Device Dislodged or Dislocated535
- Failure to Capture397
- Capturing Problem249
- High impedance167
- Activation, Positioning or Separation Problem165
- Appropriate Device Problem Term/Code Not Available154
Patient problems
- No Clinical Signs, Symptoms or Conditions1,167
- Unspecified Infection732
- No Known Impact Or Consequence To Patient501
- Undesired Nerve Stimulation218
- Muscle Stimulation184
- Device Overstimulation of Tissue181
- No Consequences Or Impact To Patient91
- Erythema57
Recent adverse event reports
The 25 most recent of 3,377 reports, in the reporter's own words as published by the FDA.
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 50935486 ↗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 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced infection. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) 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 50767789 ↗InjurySep 14, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763627 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to pocket infection with erosion, redness and discomfort. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Erosion; Erythema; Medical device site infection
MAUDE report 50757385 ↗MalfunctionSep 11, 2026Capturing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741374 ↗MalfunctionSep 11, 2026High Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited high capture 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 50734997 ↗MalfunctionSep 10, 2026High Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited higher than programmed capture 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 50716189 ↗MalfunctionSep 9, 2026Failure to Capture; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698336 ↗MalfunctionSep 4, 2026Impedance Problem
It was reported that the device was unable to be programmed to Magnetic Resonance Imaging (MRI) mode due to Out of Range (OOR) impedance values from the leads. The Right Ventricular (RV) lead and Left Ventricular (LV) lead 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 50616304 ↗InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection
MAUDE report 50597595 ↗MalfunctionSep 3, 2026Capturing Problem; Impedance Problem
Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions
MAUDE report 50595596 ↗MalfunctionSep 3, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595373 ↗MalfunctionSep 3, 2026High impedance
It was reported that the Left Ventricular (LV) lead exhibited lead impedance that was high and undefined. 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 50585034 ↗InjurySep 2, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Thrombosis/Thrombus
MAUDE report 50574332 ↗
Other permanent pacemaker Electrode devices
- CapSureFix Novus MRI™ SureScan® 5076-45Medtronic, Inc. · permanent pacemaker Electrode136 deaths16,004 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode124 deaths8,405 reports
- Capsurefix® Novus 5076-45Medtronic, Inc. · permanent pacemaker Electrode85 deaths7,050 reports
- CapSureFix Novus MRI™ SureScan™ 407652Medtronic, Inc. · permanent pacemaker Electrode69 deaths6,097 reports
- SelectSecure™ MRI SureScan™ 383069Medtronic, Inc. · permanent pacemaker Electrode56 deaths4,850 reports
- Sprint Quattro Secure® 694765Medtronic, Inc. · permanent pacemaker Electrode73 deaths3,852 reports
- CapSureFix Novus MRI™ SureScan™ 407645Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,370 reports
- CapSureFix Novus MRI™ SureScan® 5076-58Medtronic, Inc. · permanent pacemaker Electrode40 deaths3,015 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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