Attain Ability™ Plus MRI SureScan™ 429688 (UDI 00643169860131)Recalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 00643169860131), received between Oct 6, 2017 and Jul 27, 2026 — classified as 49 injuries, 31 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (28 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Extracardiac stimulation

  It was reported that the patient experienced intermittent diaphragmatic stimulation and phrenic nerve stimulation from the Left Ventricular (LV) lead. The lead was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50037461 ↗
• MalfunctionApr 17, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT "NEEDS AN MAGNETIC RESONANCE IMAGING (MRI) AND MEDTRONIC IS SAYING NO BECAUSE OF ONE OF MY LEADS." 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 24911386 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO AN INFECTION WITH REDNESS AND SWELLING AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 24581739 ↗
• MalfunctionFeb 6, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) 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 24283125 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BOTH DIAPHRAGMATIC AND PHRENIC NERVE STIMULATION POST IMPLANT PROCEDURE. THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Undesired Nerve Stimulation

  MAUDE report 24215049 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED POCKET DEHISCENCE. IT WAS ALSO REPORTED THAT THE RV LEAD WAS PARTIALLY EXPLANTED DUE TO DURING EXTRACTION EXTENSIVE CALCIFICATION AT SUPERIOR VENA CAVA (SVC) BRACHIOCEPHALIC JUNCTION. AFTER SEVERAL ATTEMPTS TO REMOVE THE RV LEAD, THE LEAD BROKE. THE RV LEAD WAS PULLED BACK INTO THE POCKET AND CUT. IT WAS ALSO REPORTED THAT THERE WAS MODERATE TO SEVERE TR (TRICUSPID REGURGITATION).

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 23501157 ↗
• InjuryOct 28, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403924 ↗
• MalfunctionOct 23, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED POTENTIAL ATRIAL UNDER SENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) EVENT(S) AT TIMES AS WELL AS UNDERSENSING ON ATRIAL LEAD APPEARS TO RESULT IN INAPPROPRIATE ATRIAL PACING. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED POSSIBLE LOSS OF CAPTURE NOTED ON THE VENTRICULAR LEAD ON STORED AND CURRENT ELECTROGRAMS (EGM). IN ADDITION HIGH RIGHT VENTRICULAR THRESHOLDS OCCURRED. 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 23373451 ↗
• InjuryOct 15, 2025Over-Sensing; Pacing Problem; High Capture Threshold; Over-Sensing; Pacing Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD SENSITIVITY WAS READJUSTED AND THE RV CAPTURE THRESHOLD IS IMPROVING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290808 ↗
• MalfunctionAug 14, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING, AND THERE WERE HIGH RIGHT VENTRICULAR (RV) CAPTURE THRESHOLDS OBSERVED. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS PACING FROM THE DEVICE'S RV PORT. 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 22804559 ↗
• MalfunctionJun 20, 2025Failure to Capture; Pacing Problem; Failure to Capture; Pacing Problem

  IT WAS FURTHER REPORTED THAT IT WAS CONFIRMED THAT UPON MORE INFORMATION THAT THE DEVICE NEEDED TO HAVE THE RV LEAD TRANSFERRED OVER FIRST. THE LV LEAD PACING WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22299564 ↗
• MalfunctionJun 16, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS IMPLANTED APPROXIMATELY ONE YEAR AND FIVE MONTHS AFTER IT'S USE BEFORE DATE. THE PHYSICIAN DEEMED IT WAS MEDICALLY NECESSARY FOR THE PATIENT TO RECEIVE THE LEAD, EVEN AFTER VERBAL AND VISUAL EXPLANATION THAT THE LEAD WAS EXPIRED AND THERE WERE NO VIABLE ALTERNATIVES ON THAT PARTICULAR DAY. THE LEAD REMAINED IN IT'S ORIGINAL PACKAGING, SEALED AND STERILE PRIOR TO IMPLANTATION. 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 22214264 ↗
• InjuryApr 24, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21901227 ↗
• MalfunctionApr 21, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD APPEARS TO BE UNDERSENSING. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) MISCLASSIFIED SUPRA VENTRICULAR TACHYCARDIA (SVT) EVENTS AS VENTRICULAR TACHYCARDIA (VT) DUE TO ATRIAL UNDERSENSING. HIGH THRESHOLD MEASUREMENTS WERE OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN IMPEDANCE WARNING DUE TO LOW IMPEDANCE MEASUREMENTS. IT WAS FURTHER REPORTED THAT THE PATIENT HAS TWO CORONARY SINUS LEADS IMPLANTED. ONE OF THE CORONARY SINUS LEADS ARE IN THE RIGHT VENTRICULAR PORT, BUT NOTHING IS IMPLANTED IN THE RIGHT VENTRICLE. THE DEVICE AND 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 21876529 ↗
• MalfunctionFeb 20, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) 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 21422479 ↗
• InjuryFeb 11, 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 INFECTED. BACTEREMIA WAS NOTED. PREOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 21353946 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS POCKET DEHISCENCE, AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPOSED. THE CRT-D 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: Wound Dehiscence

  MAUDE report 21329234 ↗
• InjuryJan 30, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS. 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 21274748 ↗
• InjuryJan 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS. THE LEAD WAS EXPLANTED AND REPLACED. DURING POST POCKET CLOSURE, THE NEWLY IMPLANTED RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD DISLODGED. BOTH LEADS WERE EXPLANTED AND REPLACED LATER THAT DAY AND CONNECTED TO A COMPETITOR DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069320 ↗
• MalfunctionDec 10, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD IMPEDANCE LVTIP TO CAN WARNING TRIGGERED FOR LOW IMPEDANCE, THE LEAD IMPEDANCE TREND HAS STABILIZED SINCE. 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 20898080 ↗
• MalfunctionNov 26, 2024Intermittent Capture; Failure to Capture; High Capture Threshold; Intermittent Capture; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD, PLUGGED INTO THE RIGHT VENTRICULAR PORT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), EXHIBITED HIGH PACING THRESHOLDS AND POSSIBLE INTERMITTENT LOSS OF CAPTURE. THE PATIENT CAME INTO THE OFFICE TO EVALUATE THRESHOLDS AND THE PRESENTING RHYTHM DEMONSTRATED POTENTIAL OF NON-CAPTURE. IT WAS NOTED THAT OUTPUT WAS SET SLIGHTLY ABOVE THRESHOLD. 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 20785229 ↗
• InjuryOct 29, 2024Device Dislodged or Dislocated; High Capture Threshold; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE EFFECTIVE CARDIAC RESYNCHRONIZATION THERAPY (CRT) PACING PERCENTAGE HAD DECREASED SIGNIFICANTLY. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLDS WERE HIGH, AND A CHEST X-RAY SHOWED THAT THE LV LEAD HAD MIGRATED AND WAS SIGNIFICANTLY RETRACTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559712 ↗
• InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO INFECTED LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20465955 ↗
• MalfunctionOct 2, 2024Over-Sensing; Pacing Problem; Impedance Problem; High Capture Threshold; Unstable Capture Threshold; Over-Sensing; Pacing Problem; Impedance Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD PLUGGED INTO THE RIGHT VENTRICULAR (RV) PORT EXHIBITED OVERSENSING INHIBITION OF PACING, AND CROSSTALK ALL NOTED ON THE CURRENT ELECTROGRAM (EGM). THE TRENDS ON THE INTERROGATION REPORT SHOWED DECLINING UNIPOLAR AND BIPOLAR IMPEDANCES, FLUCTUATIONS IN THRESHOLDS, AND HIGH THRESHOLDS ON THE LEAD. SHORT VENTRICULAR INTERVALS WERE ALSO NOTED. 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 20353402 ↗
• InjurySep 29, 2024Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXHIBITED HEART RATES IN THE 40S. IT WAS OBSERVED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND A POSSIBLE LOSS OF CAPTURE. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON CURRENT AND STORED E LECTROGRAMS (EGM), POSSIBLY RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RECORDED EPISODES. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF TH IS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20329492 ↗