Attain PerformaRecalls & reported problems across all models

We found 2 models of Attain Performa by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 749 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2015 and Sep 28, 2026 — classified as 10 deaths, 550 injuries, 189 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (212 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 problems

Attain Performa models

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

• Attain® Performa™ 429888

  permanent pacemaker Electrode
  7 deaths606 reports
• Attain® Performa™ 429878

  permanent pacemaker Electrode
  3 deaths143 reports

Recent Attain Performa adverse event reports

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

• MalfunctionSep 28, 2026Capturing Problem; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921839 ↗
• InjurySep 23, 2026Capturing Problem

  It was reported that the Left Ventricular (LV) lead "thresholds "[were]" leading to increased battery drain" from the Cardiac Resynchronization Therapy Defibrillator (CRT-D). The lead was reprogrammed, and the lead and the device 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 50873457 ↗
• MalfunctionSep 17, 2026High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited high capture 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 50802038 ↗
• InjurySep 10, 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 an infection with Endocarditis. No further patient complications have been reported as a result of this event.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 50717050 ↗
• MalfunctionSep 10, 2026High Capture Threshold

  It was reported that that the Left Ventricular (LV) lead exhibited possible 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 50705484 ↗
• MalfunctionSep 8, 2026High impedance

  It was reported that the lead exhibited high impedance and Magnetic Resonance Imaging (MRI) Surescan mode could not be programmed for the device as a result. 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 50664170 ↗
• InjuryAug 25, 2026High impedance

  It was reported that the Left Ventricular (LV) lead triggered multiple alerts for undefined high pacing impedance. The lead was reprogrammed and 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 50432614 ↗
• InjuryAug 20, 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 infection. The patient was experiencing discomfort, redness, and swelling. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 50354392 ↗
• InjuryJun 26, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND POSSIBLE LOSS OF CAPTURE. THE PATIENT WAS EXPERIENCING SYNCOPE. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25643931 ↗
• MalfunctionMay 27, 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 25306249 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO THE PATIENT DEVELOPING ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Endocarditis

  MAUDE report 25230599 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION WITH PURULENT DISCHARGE AND PUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 25222078 ↗
• InjuryApr 29, 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 25029576 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO CHRONIC SWELLING. THE PATIENT EXPERIENCED INDURATION AND GRANULOMA. THE SYSTEM WAS REPLACED WITH A SINGLE CHAMBER PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Granuloma; Hypersensitivity/Allergic reaction; Swelling/ Edema; Unspecified Skin and Subcutaneous Tissue Problem

  MAUDE report 24817486 ↗
• InjuryApr 8, 2026Fracture; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. THERE WAS VEGETATION OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD, AND THE PATIENT HAD A POSITIVE CULTURE FOR KLEBSIELLA PNEUMONIAE. DURING EXPLANT, THE LEFT VENTRICULAR (LV) LEAD FRACTURED DISTALLY BEFORE THE ENTIRE LEAD COULD BE FULLY REMOVED. MOST OF THE LV LEAD WAS REMOVED EXCEPT FOR THE TIP, WHICH REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24817278 ↗

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