Attain Performa™ S MRI SureScan™ 459888Recalls & reported problems
Medtronic, Inc. · LEAD 459888 MRI S-TIP US · Class 3 · Implant
All models of Attain Performa S MRI SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Attain Performa lead is an implanted wire that carries pacing signals from a pacemaker to the heart. Its 2,362 reports often describe the lead failing to pace the heart, needing too much energy to do so, and the lead moving out of place, and mention 33 deaths and 1,448 injuries. Some also mention infection and unwanted nerve or muscle stimulation. No recalls name this device.
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
- 2,374
- Deaths reported
- 33
- Injuries reported
- 1,455
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,374 adverse event reports that list this exact device (DI 00643169601871), received between Dec 9, 2016 and Sep 30, 2026 — classified as 33 deaths, 1,455 injuries, 886 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (554 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 Problem889
- High Capture Threshold554
- Failure to Capture276
- Device Dislodged or Dislocated271
- Capturing Problem190
- Activation, Positioning or Separation Problem179
- High impedance130
- Impedance Problem129
Patient problems
- No Clinical Signs, Symptoms or Conditions890
- Unspecified Infection490
- No Known Impact Or Consequence To Patient315
- Undesired Nerve Stimulation142
- Device Overstimulation of Tissue135
- Muscle Stimulation106
- No Consequences Or Impact To Patient67
- Erythema51
Recent adverse event reports
The 25 most recent of 2,374 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952547 ↗InjurySep 30, 2026Intermittent Capture; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951877 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to an infection resulting in discomfort, erosion, redness, swelling and wound dehiscence. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Erosion; Erythema; Swelling/ Edema; Unspecified Infection; Wound Dehiscence
MAUDE report 50934517 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50923749 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection
MAUDE report 50891966 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that three months post Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant, the patient experienced a device pocket infection, discomfort, pain, purulent discharge, redness, and swelling. The CRT-D system was explanted and then replaced six days later. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Purulent Discharge; Swelling/ Edema
MAUDE report 50888930 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to a mobile echogenic mass/vegetation attached to the Right Atrial (RA) lead. It was noted that the patient also experienced discomfort. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Medical device site infection
MAUDE report 50882162 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50828438 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacterial Infection
MAUDE report 50781043 ↗MalfunctionSep 15, 2026Activation, Positioning or Separation Problem; Device Dislodged or Dislocated
It was reported that during an implant procedure a guidewire was unable to smoothly track through the Left Ventricular (LV) lead. When the wire was pulled back the lead came with it. The LV lead was removed and replaced with a new lead. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777543 ↗InjurySep 14, 2026Extracardiac stimulation
It was reported that three transmissions were missing current electrograms (EGM). The Cardiac Resynchronization Therapy Pacemaker (CRT-P) remains in use. It was further noted that the patient experienced diaphragmatic stimulation and the Left Ventricular (LV) lead was reprogrammed. No further patient complications have been reported as a result of this event.
Patient problems: Device Overstimulation of Tissue
MAUDE report 50754068 ↗MalfunctionSep 10, 2026Capturing Problem; Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722193 ↗MalfunctionSep 8, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50679164 ↗MalfunctionSep 8, 2026Low impedance; High Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited high capture thresholds and 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 50674959 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Abscess; Fever; Unspecified Infection
MAUDE report 50618344 ↗MalfunctionSep 4, 2026Capturing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50617216 ↗MalfunctionSep 2, 2026Capturing Problem
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50571587 ↗MalfunctionSep 2, 2026Extracardiac stimulation; High Capture Threshold
Patient problems: Dyspnea; Inappropriate Device Stimulation of Tissue
MAUDE report 50570315 ↗MalfunctionAug 26, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50460482 ↗MalfunctionAug 24, 2026Failure to Capture
It was reported that there was a position check failure on the Right Atrial (RA) lead. It was also reported that the Left Ventricular (LV) lead exhibited loss of capture. The RA lead and 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 50414028 ↗MalfunctionAug 21, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50375227 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed a bacteremia infection. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia
MAUDE report 50355664 ↗MalfunctionAug 19, 2026Activation, Positioning or Separation Problem; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50326096 ↗InjuryAug 17, 2026Extracardiac stimulation
It was reported that approximately four weeks after implant, the patient experienced phrenic nerve stimulation. The Left Ventricular (LV) lead was explanted and replaced with another model in an alternate location. No further patient complications have been reported as a result of this event.
Patient problems: Device Overstimulation of Tissue
MAUDE report 50288921 ↗MalfunctionAug 13, 2026High Capture Threshold
Patient problems: Fall
MAUDE report 50237278 ↗
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
- Attain Performa™ MRI SureScan™ 429888Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,377 reports
- CapSureFix Novus MRI™ SureScan™ 407645Medtronic, Inc. · permanent pacemaker Electrode38 deaths3,370 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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