Attain Stability™ Quad MRI SureScan™ 479888Recalls & reported problems
Medtronic, Inc. · LEAD 479888 ATTAIN MRI US · Class 3 · Implant
All models of Attain Stability Quad MRI SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medtronic Attain Stability Quad MRI heart pacing lead has 2,175 reports, which include 27 deaths and 1,337 injuries. Many describe the lead needing high electrical output to stimulate the heart, failing to do so, or moving out of place. Some mention infection and surgery to replace the lead. 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
- 2,213
- Deaths reported
- 28
- Injuries reported
- 1,353
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,213 adverse event reports that list this exact device (DI 00643169860421), received between Jun 27, 2019 and Sep 30, 2026 — classified as 28 deaths, 1,353 injuries, 832 malfunctions.
The most frequently reported specific device problem is “High Capture Threshold” (451 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 Problem833
- High Capture Threshold451
- Device Dislodged or Dislocated321
- Failure to Capture280
- Capturing Problem174
- High impedance132
- Activation, Positioning or Separation Problem111
- Low impedance88
Patient problems
- No Clinical Signs, Symptoms or Conditions1,050
- Unspecified Infection392
- Device Overstimulation of Tissue186
- Undesired Nerve Stimulation140
- No Consequences Or Impact To Patient83
- No Known Impact Or Consequence To Patient77
- Erythema63
- Discomfort62
Recent adverse event reports
The 25 most recent of 2,213 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Extracardiac stimulation
It was reported that the patient complained of diaphragmatic stimulation after eating causing discomfort. The Left Ventricular (LV) lead was reprogrammed to mitigate the symptoms. It was also noted that the Right Atrial (RA) lead exhibited variable impedance and somewhat elevated in the pacing impedance trends. Additionally, the Right Ventricular (RV) lead exhibited increasing thresholds initially, but had stabilized. All three leads remain in use. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Inappropriate Device Stimulation of Tissue
MAUDE report 50950550 ↗MalfunctionSep 30, 2026Contamination; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949292 ↗InjurySep 30, 2026Low impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949036 ↗MalfunctionSep 29, 2026Capturing Problem; High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937944 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50935756 ↗MalfunctionSep 29, 2026Failure to Capture
It was reported that the Left Ventricular (LV) lead exhibited possible loss of capture. 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 50935188 ↗InjurySep 25, 2026Extracardiac stimulation
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50905900 ↗MalfunctionSep 25, 2026Impedance Problem
It was reported that the Right Ventricular (RV) lead exhibited an acute drop in pacing impedance and an acute rise to high thresholds. The Left Ventricular (LV) lead also exhibited an acute drop 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 50896592 ↗InjurySep 24, 2026High Capture Threshold
It was reported that high Left Ventricular (LV) lead thresholds were observed which depleted the Cardiac Resynchronization Therapy D efibrillator (CRT-D) battery. The CRT-D was explanted and replaced; the LV 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 50889012 ↗MalfunctionSep 24, 2026Intermittent Capture
It was reported that the Left Ventricular (LV) lead exhibited intermittent loss of capture. The LV lead remains in use. No patient c omplications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885633 ↗InjurySep 24, 2026Device Dislodged or Dislocated; High Capture Threshold
It was reported that the Left Ventricular (LV) lead had a history of high thresholds and had a suspected microdislodgement. The LV lead vector was previously reprogrammed. 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 50884879 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection and septic shock. A leadless Implantable Pulse Generator (IPG) was implanted. No further patient complications have been reported as a result of this event.
Patient problems: Septic Shock; Unspecified Infection
MAUDE report 50870669 ↗InjurySep 23, 2026Extracardiac stimulation
It was reported that the patient was feeling unwell and experienced possible extracardiac stimulation from the Left Ventricular (LV) lead pacing. It was further reported that the LV lead was programmed off because the patient was experiencing discomfort and anxiety. No further patient complications have been reported as a result of this event.
Patient problems: Anxiety; Discomfort
MAUDE report 50869709 ↗InjurySep 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829644 ↗InjurySep 16, 2026Extracardiac stimulation
It was reported that the patient experienced phrenic nerve stimulation from the Left Ventricular (LV) lead. The lead was reprogrammed and remains in use. No further patient complications have been reported as a result of this event.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50793950 ↗MalfunctionSep 16, 2026High Capture Threshold
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793603 ↗MalfunctionSep 16, 2026High impedance; High Capture Threshold
It was reported that the Right Atrial (RA) lead exhibited under sensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected events in progress. The Left Ventricular (LV) lead exhibited Out of Range (OOR) high pacing impedance and high threshold. 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 50789986 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) device system was explanted due to a pocket infection with purulent discharge. No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection; Purulent Discharge
MAUDE report 50787156 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced a pocket infection, erosion and wound dehiscence. 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: Erosion; Medical device site infection; Wound Dehiscence
MAUDE report 50776925 ↗MalfunctionSep 14, 2026Low impedance
It was reported that the Right Atrial (RA) lead exhibited low pacing impedance, high threshold, and atrial capture could not be confirmed. The Atrial Lead Position Check (ALPC) failed due to an unknown cause. Also, the Left Ventricular (LV) lead exhibited low pacing impedance. The patient experienced symptoms of congestive heart failure and shortness of breath. The RA lead and LV lead remain in use. No further patient complications have been reported as a result of this event.
Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure
MAUDE report 50752816 ↗MalfunctionSep 11, 2026Electrical /Electronic Property Problem; High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739415 ↗MalfunctionSep 11, 2026Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735127 ↗InjurySep 10, 2026Extracardiac stimulation
It was reported that the patient received possible inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy from the Cardiac Resynchronization Therapy Defibrillator (CRT-D) for Atrial Fibrillation (AF) with rapid ventricular response that was detected as Ventricular Fibrillation (VF). The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) that resulted in termination of AT/AF detected events and unnecessary atrial pacing. The patient also experienced phrenic nerve stimulation from the Left Ventricular (LV) lead. The LV lead was reprogrammed. The RA lead, LV lead, and CRT-D remain in use. No further patient complications have been reported as a result of this event.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50718144 ↗InjurySep 10, 2026Capturing Problem; Unstable Capture Threshold
It was reported that the Left Ventricular (LV) lead exhibited rising and unstable thresholds. 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 50715953 ↗MalfunctionSep 10, 2026High impedance
It was reported that the Right Atrial (RA) lead exhibited undersensing resulting in misclassification of episode detection, and the Left Ventricular (LV) lead exhibited undefined high pacing impedance. 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 50714586 ↗
Other Drug eluting permanent left ventricular (lv) pacemaker electrode devices
- Attain Performa™ Straight MRI SureScan™ 439888Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode26 deaths1,595 reports
- Sentus ProMRI OTW QP L-85/49 408719BIOTRONIK SE & Co. KG · Drug eluting permanent left ventricular (lv) pacemaker electrode7 deaths1,385 reports
- Quartet™ 1457Q-86St. Jude Medical, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode21 deaths1,061 reports
- Quickflex™ 1258TSt. Jude Medical, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode26 deaths996 reports
- ATTAIN® BIPOLAR OTW 419488Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode15 deaths730 reports
- Attain Ability® Plus 429688Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode11 deaths529 reports
- Sentus ProMRI OTW QP S-85/49 406082BIOTRONIK SE & Co. KG · Drug eluting permanent left ventricular (lv) pacemaker electrode1 death511 reports
- ATTAIN® BIPOLAR OTW 419478Medtronic, Inc. · Drug eluting permanent left ventricular (lv) pacemaker electrode5 deaths464 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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