Attain Performa™ S MRI SureScan™ 459878Recalls & reported problems

Summary

The FDA's MAUDE database contains 451 adverse event reports that list this exact device (DI 00643169601864), received between Dec 9, 2016 and Sep 14, 2026 — classified as 5 deaths, 282 injuries, 164 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (102 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 451 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 50762408 ↗
• MalfunctionAug 25, 2026Impedance Problem; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited intermittent/inconsistent capture. The RA lead was explanted and replaced. It was also reported that the Left Ventricular (LV) lead triggered a impedance warning LV2 to RV coil and the lead exhibited pos sible high thresholds. The LV was reused/reconnected and 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 50433193 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a Leadless implantable pulse generator (IPG). No additional details were provided. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50382557 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced due to pocket infection and discomfort. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50147893 ↗
• MalfunctionJul 13, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25804699 ↗
• MalfunctionJul 8, 2026High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH UNDEFINED PACING IMPEDANCE. 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 25750492 ↗
• MalfunctionJun 23, 2026Capturing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A SUDDEN INCREASE AND VARIATION IN CAPTURE THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 25602364 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25599769 ↗
• MalfunctionApr 29, 2026Failure to Capture; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY DEPARTMENT DUE TO CHEST PAINS. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH AND VARIABLE CAPTURE THRESHOLDS. IT WAS FURTHER REPORTED THAT THE LV LEAD HAS A HISTORY OF LOSS OF CAPTURE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 25035452 ↗
• InjuryApr 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. 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 25017987 ↗
• InjuryApr 24, 2026Intermittent Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT CAPTURE. THE LEAD EXHIBITED A MICRO DISLODGEMENT POST POC KET CLOSURE. 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 24988195 ↗
• InjuryApr 21, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED POST POCKET CLOSURE. THE LV LEAD WAS REVISED. THE LV LEAD LATER DISLODGED A SECOND TIME. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNSTABLE THRESHOLDS, UNDERSENSING, AND WAS DETERMINE TO HAVE DISLODGED. IT WAS NOTED THAT THE RA LEAD MEASUREMENTS WERE STABLE WHEN THE PATIENT WAS LYING DOWN BUT UNSTABLE WHEN SITTING UP. THE LV AND RA LEADS WERE 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 24941219 ↗
• MalfunctionApr 15, 2026High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH 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 24886242 ↗
• InjuryMar 31, 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 BACTERIAL INFECTION. IT WAS NOTED THAT THERE WAS BACTERIAL GROWTH ON THE LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 24747335 ↗
• MalfunctionMar 31, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT RECEIVED POTENTIAL INAPPROPRIATE THERAPY DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR), THAT THE DEVICE DETECTED AS VENTRICULAR TACHYCARDIA (VT). IN ADDITION, THERE WAS POSSIBLE LOSS OF CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND 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 24743417 ↗
• InjuryMar 30, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO THE PATIENT HAVING EXTREME POCKET PAIN WITH DEVICE ON LEFT SIDE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Pain

  MAUDE report 24737526 ↗
• MalfunctionMar 30, 2026Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT THERE WAS A DECREASE AND VARYING IMPEDANCE ON THE RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO NOTED THERE WAS UNDERSENSING ON THE RA LEAD RESULTING IN FALSE TERMINATION OF STORED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AND UNNECESSARY PACING. THE LEADS 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 24716810 ↗
• InjuryMar 18, 2026Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV 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 24634710 ↗
• InjuryMar 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS A MICRO-DISLODGEMENT OF THE LEFT VENTRICULAR (LV) LEAD POST POCKET CLOSURE. THE LV 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 24508395 ↗
• InjuryMar 3, 2026Extracardiac stimulation

  IT WAS REPORTED BY THE PATIENT THAT WITHIN ONE DAY OF IMPLANT, THEY FELT A THUMPING/VIBRATION FEELING IN THEIR LATERAL LEFT CHEST WALL, RIBS AND BACK. THE PATIENT WAS ADMITTED AND DIAGNOSED WITH REPRODUCIBLE PHRENIC STIMULATION SYMPTOMS. LEFT VENTRICULAR (LV) LEAD REPROGRAMMING WAS PERFORMED WITH GOOD PACING AND NO FURTHER PHRENIC STIMULATION. THE PATIENT WAS DISCHARGED HOME. THE LV LEAD 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 24503836 ↗
• MalfunctionFeb 25, 2026Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW IMPEDANCE. 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 24443914 ↗
• InjuryFeb 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 BACTEREMIA, SEPTIC SHOCK, AND CARDIOGENIC SHOCK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Cardiogenic Shock; Septic Shock

  MAUDE report 24437075 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST GENERATOR CHANGE, 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 24377179 ↗
• MalfunctionFeb 10, 2026Extracardiac stimulation; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. IT WAS STATED THAT THE PATIENT HAD A HISTORY OF PHRENIC NERVE STIMULATION. 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 24308548 ↗
• MalfunctionFeb 9, 2026High 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 24290901 ↗