ATTAIN® PERFORMA™ S 459888Recalls & reported problems

Summary

The FDA's MAUDE database contains 250 adverse event reports that list this exact device (DI 00643169169081), received between Oct 1, 2015 and Sep 16, 2026 — classified as 1 death, 174 injuries, 75 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (67 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 250 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryAug 22, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WAS "DEFECTIVE" AND HAD TO BE REPLACED. IT WAS FURTHER REPORTED THAT THE CRTD WAS REPLACED ELECTIVELY DUE TO LOW BATTERY. IT WAS ALSO STATED THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING THRESHOLD. THE LEAD WAS DEACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22876032 ↗
• MalfunctionJul 23, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS WERE NOTED. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF A THRESHOLD VALUE. THE LV LEAD AND CRT-D 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 22580358 ↗
• InjuryJul 16, 2025Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD WERE LATER EXPLANTED AND REPLACED WHEN THE PATIENT WAS DOWNGRADED TO A BIVENTRICULAR PACEMAKER SYSTEM, AND THE LEFT VENTRICULAR (LV) LEAD REMA INS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22522293 ↗
• MalfunctionJul 1, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SHORTNESS OF BREATH, UPON REVIEW IT WAS NOTED THAT LEFT VENTRICULAR (LV) LEAD CAPTURE COULD NOT BE CONFIRMED DURING STORED EPISODES BUT THRESHOLDS APPEARED STABLE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 22374012 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH AN TIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT EXPERIENCED A POCKET INFECTION WITH BACTEREMIA. THE PATIENT RECEIVED ANTIBIOTICS. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Medical device site infection

  MAUDE report 22140571 ↗
• InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD, AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED DUE TO A DEVICE POCKET SITE INFECTION AND SWELLING WAS ALSO OBSERVED. IT WAS NOTED THAT A CULTURE WAS TAKEN AND WAS POSITIVE FOR CUTIBACTERIUM ACNES. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED AFTER SYSTEM EXPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 22018713 ↗
• InjuryApr 16, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT HAD A NECK WOUND. ADDITIONALLY, THE PATIENT EXPERIENCED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION AND FEVER. THE CRT-D SYSTEM WAS EXPLANTED. DURING EXTRACTION OF THE LEFT VENTRICULAR (LV) LEAD, PART OF THE LEAD SEPARATED DURING THE EXTRACTION AND PART OF THE INSULATION AND THE FOUR ELECTRODES REMAIN IN THE PATIENT'S BODY. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTIC MEDICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Fever

  MAUDE report 21852772 ↗
• InjuryFeb 26, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH IMPEDANCE AND HIGH THRESHOLD. THE LEAD WAS TURNED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468521 ↗
• MalfunctionFeb 25, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD CAPTURE WAS SET TO MONITOR. THE LV LEAD TRENDS SHOWED SOME DAILY MEASUREMENTS AT OR ABOVE CAPTURE, POSSIBLY LEADING TO 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 21464637 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. IT WAS SUSPECTED THAT THE SOURCE OF THE INFECTION WAS POSSIBLY AN INFECTED TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21439150 ↗
• InjuryFeb 21, 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 EXPLANTED DUE TO A SUSPECTED POCKET INFECTION AND THE ORGANISM WAS REPORTED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. ADDITIONALLY, THE PATIENT EXPERIENCED BACTEREMIA WITH DISCOMFORT AND REDNESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Discomfort; Drug Resistant Bacterial Infection; Erythema; Fluid Discharge; Medical device site infection; Pain; Wound Odor

  MAUDE report 21439116 ↗
• MalfunctionFeb 18, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND CAPTURE COULD NOT BE CONFIRMED. IT WAS NOTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND SHORTNESS OF BREATH. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 21403123 ↗