Attain Performa™ MRI SureScan™ 429878Recalls & reported problems

Summary

The FDA's MAUDE database contains 809 adverse event reports that list this exact device (DI 00643169601826), received between Oct 6, 2016 and Sep 30, 2026 — classified as 14 deaths, 560 injuries, 235 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (177 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 809 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 50953779 ↗
• InjurySep 29, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940893 ↗
• InjurySep 29, 2026Extracardiac stimulation; High Capture Threshold

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50933210 ↗
• InjurySep 15, 2026Insufficient Device Problem Information

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was removed for unknown reasons. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771862 ↗
• InjurySep 1, 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 a Methicillin-resistant Staphylococcus aureus infection. No further patient complications have been reported as a result of this event.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 50547545 ↗
• MalfunctionAug 27, 2026Unstable Capture Threshold

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to an increase in Sensing Integrity Counter (SIC) and two or more High Rate-Non Sustained episodes. Additionally, the lead exhibited noise, a spike in pacing impedance, and oversensing resulting in misclassification of episode type. It was also reported that the Left Ventricular (LV) lead exhibited higher thresholds when the patient was "laying down vs seated." 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 50471641 ↗
• MalfunctionAug 21, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50381113 ↗
• InjuryAug 20, 2026High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited high thresholds. The LV lead was explanted and replaced. No patient co mplications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354767 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had developed a bacteremia infection. Additionally, the patient had a fever and pain. The Cardiac R esynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a leadless pacemaker a few days later. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Fever; Pain

  MAUDE report 50166709 ↗
• MalfunctionAug 5, 2026Capturing Problem; Impedance Problem

  It was further reported that the LV lead was reprogrammed and remains in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50147277 ↗
• InjuryJul 8, 2026Extracardiac stimulation

  IT WAS REPORTED THAT THE PATIENT WAS POST-OPERATIVELY EXPERIENCING DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. PACING AMPLITUDE AND POLARITY WERE ADJUSTED WITH NO FURTHER REPORTS OF STIMULATION. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 25748909 ↗
• InjuryJul 6, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH DIZZINESS/PRESYNCOPE. IT WAS REPORTED THAT THE PATIENT FELT PACING ON THEIR CHEST WALL AND THAT THEY FELT "LIKE IT WENT FLAT" BEFORE NEARLY PASSING OUT. THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Presyncope

  MAUDE report 25714985 ↗
• InjuryJun 30, 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25670574 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AFTER UPGRADING TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) THE PATIENT EXPERIENCED A POCKET HEMATOMA THAT BECAME INFECTED. THE 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: Hematoma; Medical device site infection

  MAUDE report 25666012 ↗
• MalfunctionJun 24, 2026Impedance Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POTENTIALLY INAPPROPRIATELY WITHHELD THERAPY BY SVT (SINUS TACH) DISCRIMINATOR FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF). THE CRT-D REMAINS IN USE. IT WAS ALSO REPORTED THAT LEFT VENTRICULAR (LV) LEAD IMPEDANCE DECREASED. THE LV LEAD REMAINS IN USE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED DIMINISHED/DECREASE IN P WAVE AMPLITUDE. THE RA 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 25613096 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25561971 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TEN WEEKS AFTER A DEVICE EXCHANGE PROCEDURE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A DEVICE POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25355618 ↗
• MalfunctionMay 26, 2026Capturing Problem; Device Dislodged or Dislocated; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A DROP IN IMPEDANCE AND RISING THRESHOLDS AND THE LV LEAD WAS SUSPECTED TO BE DISLODGED. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND UNDERSENSING AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE RV LEAD, LV LEAD, AND RA 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 25280214 ↗
• MalfunctionMay 18, 2026Failure to Capture

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INAPPROPRIATELY WITHHELD THERAPY FOR A VENTRICULAR ARRHYTHMIA. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN UNNECESSARY PACING AT TIMES, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOSS OF CAPTURE POST THERAPY DELIVERY, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING. THE CRT-D, RA LEAD, LV LEAD AND RV 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 25209760 ↗
• MalfunctionMay 11, 2026Extracardiac stimulation; Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW PACING IMPEDANCE. THE PATIENT EXPERIENCED "PACING STIMULATION." THE 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 25143542 ↗
• MalfunctionApr 20, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED ELEVATED BUT STABLE THRESHOLDS. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED REDUCED DEVICE LONGEVITY OF LESS THAN FOUR YEARS DUE TO THE CHRONIC, ELEVATED BUT STABLE LEAD THRESHOLDS. THE CRT-P WAS EXPLANTED AND REPLACED, AND 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 24928128 ↗
• DeathApr 11, 2026Failure to Capture; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISPLAYED UNDERSENSING RESULTING IN UNNECESSARY PACING AT TIMES AND FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS. APPROXIMATELY THREE DAYS LATER, THE PATIENT PASSED AWAY. A REMOTE MONITORING TRANSMISSION WAS SENT THE NEXT DAY AND INDICATED THERE WERE HIGH RA LEAD AND LEFT VENTRICULAR (LV) LEAD THRESHOLDS. ADDITIONALLY, THE RA LEAD, LV LEAD, AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED A LOSS OF CAPTURE IN PACING IMPEDANCES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24849141 ↗
• MalfunctionApr 9, 2026Capturing Problem

  IT WAS REPORTED THAT THERE WAS AN INCREASE IN LEFT VENTRICULAR (LV) LEAD CAPTURE THRESHOLDS NOTED ON LEAD TRENDS. 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 24835431 ↗
• 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 INFECTION. IN ADDITION, THE PATIENT EXPERIENCED PURULENT DISCHARGE AND WOUND DEHISCENCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 24745054 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT OF A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT PRESENTED WITH AN INFECTION. THE CRTP SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24698903 ↗