ATTAIN PERFORMA SRecalls & reported problems across all models

We found 2 models of ATTAIN PERFORMA S by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 324 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2015 and Sep 16, 2026 — classified as 4 deaths, 217 injuries, 103 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (92 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ATTAIN PERFORMA S problems

ATTAIN PERFORMA S models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ATTAIN® PERFORMA™ S 459888

  permanent pacemaker Electrode
  1 death250 reports
• ATTAIN® PERFORMA™ S 459878

  permanent pacemaker Electrode
  3 deaths74 reports

Recent ATTAIN PERFORMA S adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Extracardiac stimulation

  It was reported that during use of the Left Ventricular (LV) lead, the patient experienced Diaphragmatic nerve stimulation and discomfort. The 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; Discomfort

  MAUDE report 50792654 ↗
• MalfunctionSep 10, 2026Intermittent Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717737 ↗
• MalfunctionSep 9, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698957 ↗
• MalfunctionAug 26, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457970 ↗
• InjuryJul 9, 2026Impedance Problem

  IT WAS REPORTED BY THE PATIENT THAT FOLLOWING A REVISION PROCEDURE, THEY CALLED AND ASKED WHY A NEW LEAD HAD BEEN IMPLANTED AND WHETHER THE PREVIOUS LEAD WAS DEFECTIVE. THE PATIENT STATED THAT THE PHYSICIAN DISCUSSED HIGH IMPEDANCE, POSSIBLE FIBROSIS, AND THAT THE REPLACEMENT LEAD WAS PLACED IN A DIFFERENT LOCATION. THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fibrosis

  MAUDE report 25770457 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, AND THE SOURCE OF INFECTION WAS STATED TO BE POSSIBLY FROM THE BLOOD IN ADDITION TO BACTEREMIA. 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: Bacteremia; Sepsis; Unspecified Infection

  MAUDE report 24734443 ↗
• InjuryMar 3, 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 PACEMAKER DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24500314 ↗
• InjuryFeb 24, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN FAILURE TO MEET DEVICE CLASSIFIED EPISODE D ETECTION CRITERIA. THE RV UNDERSENSING CAUSED DELAYED DETECTION FOR FAST VENTRICULAR TACHYCARDIA (FVT) AND VENTRICULAR FIBRILLATION (VF). IN ADDITION, THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR HIGH UNDEFINED PACING IMPEDANCES. THE LV LEAD HAS BEEN PROGRAMMED OFF. THE RV AND LV LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 24430526 ↗
• InjuryFeb 10, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO THE PRESENCE OF VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS DIAGNOSED WITH ENDOCARDITIS. DURING THE PROCEDURE, ATTEMPTS TO REMOVE THE LEFT VENTRICULAR (LV) LEAD RESULTED IN ELECTRODE BREAKAGE; THE BROKEN ELECTRODES COULD NOT BE RETRIEVED AND WERE THEREFORE ABANDONED IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 24306557 ↗
• InjuryNov 13, 2025Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT CAPTURE. THE LEAD WAS CAPPED 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 23547439 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTRACARDIAC 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: Device Overstimulation of Tissue

  MAUDE report 23090276 ↗
• MalfunctionSep 8, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH THRESHOLDS ON THE LEFT VENTRICULAR (LV) LEAD. THE CRT-D WAS EXPLANTED AND REPLACED, AND 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 22994386 ↗
• MalfunctionSep 5, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE INTERMITTENT LOSS OF CAPTURE. 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 22980729 ↗
• MalfunctionAug 29, 2025High Capture Threshold; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE INITIAL ATTEMPT LV LEAD HIGH THRESHOLD WAS DUE TO PATIENT ANATOMY WHILE PLACING THE LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929127 ↗
• MalfunctionAug 27, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW R-WAVES CORRELATING WITH VARYING AND HIGH THRESHOLDS. THE RV LEAD WAS EXPLANTED AND REPLACED. IN ADDITION, 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 22905255 ↗

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