Attain® Performa™ 429878Recalls & reported problems

Summary

The FDA's MAUDE database contains 143 adverse event reports that list this exact device (DI 00643169002685), received between Apr 7, 2016 and Sep 28, 2026 — classified as 3 deaths, 91 injuries, 49 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (43 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 143 reports, 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 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 ↗
• 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 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 ↗
• MalfunctionApr 2, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR PALPITATIONS. INFORMATION RECEIVED ON THE REMOTE TRANSMISSION WAS REVIEWED BY QUALIFIED PERSONNEL. IT WAS DETERMINED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN THRESHOLDS BEGINNING SEVERAL MONTHS PRIOR. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Palpitations

  MAUDE report 24766156 ↗
• InjuryFeb 17, 2026Positioning Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE IN THE HOSPITAL BECAUSE OF A FAINTING SPELL AND "PASSED OUT" THE DAY PRIOR. THE PATIENT STATED THAT "THEY SHOWED A TACHYCARDIA OR SOMETHING IN MY HEART THING". ADDITIONALLY, THE PATIENT MENTIONED THE PHYSICIAN THAT IMPLANTED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SAID ONE OF THE LEADS WAS NOT PLACED RIGHT IN THEIR "FIRST ONE" AND WHEN THE PATIENT FAINTED, THE DEFIBRILLATION "DID NOT GO OFF". THE PATIENT ALSO STATED THE LEFT VENTRICULAR (LV) LEAD WAS NOT PLACED PROPERLY SO INSTEAD OF GOING IN TO RECONNECT THE LEAD, "IT WAS HARD FOR THEM TO SYNC BETWEEN THE RIGHT VENTRICULAR (RV) LEAD AND THE LV LEAD". IN ADDITION, THE PATIENT SAID THAT WHEN THEY WERE IN THE HOSPITAL, THE STAFF TOLD THEM THAT THE REASON THEY FAINTED WAS BECAUSE OF ATRIAL FIBRILLATION (AF) AND THAT THEIR DEVICE SHOULD HAVE GONE OFF. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Syncope/Fainting; Tachycardia

  MAUDE report 24368743 ↗
• InjuryFeb 16, 2026Pacing Problem

  IT WAS REPORTED THAT SHORTLY AFTER LEFT VENTRICULAR (LV) LEAD PLACEMENT, LV PACING INDUCED VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) AND RESULTED IN THERAPIES. THE LEAD WAS PROGRAMMED OFF AND WAS LATER CAPPED AND REPLACED WITH A LEFT BUNDLE BRANCH LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 24349290 ↗
• InjuryFeb 9, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A CONFIRMED LOW VOLTAGE FRACTURE AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD AND LV LEAD WERE 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 24293067 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN INFECTION. A POSSIBLE VEGETATION WAS NOTED ON THE LEFT VENTRICULAR (LV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 23809848 ↗
• InjuryNov 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 BACTEREMIA INFECTION. A TEMPORARY DEVICE WAS PLACED UNTIL A NEW CRT-D SYSTEM WAS IMPLANTED A WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 23616774 ↗
• InjuryOct 15, 2025High Capture Threshold; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE LV LEAD OUTPUT WAS CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280701 ↗
• MalfunctionJun 20, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD AND HIGH PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. 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 22297862 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR ¿HEART GOT INFECTED¿ AND THEY HAD TO TAKE OUT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE RIGHT ATRIAL (RA) LEAD, LEFT VENTRICULAR (LV) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE CAPPED. THE CRT-D SYSTEM WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22207145 ↗
• InjuryApr 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED APPROXIMATELY TWO AND A HALF MONTHS POST-GENERATOR REPLACEMENT PROCEDURE WITH USE OF AN ANTIBACTERIAL ABSORBABLE ENVELOPE. THE SKIN ABOVE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RED, PURPLE, SWOLLEN, PAINFUL, WARM TO THE TOUCH WITH POSSIBLE ABSCESS, WITH REDNESS EXTENDING AROUND THE DEVICE TOWARDS THE NECK, AND THE PATIENT HAD A FEVER. THE PATIENT WAS ADMITTED FOR ADMINISTRATION OF INTRAVENOUS ANTIBIOTICS. THE PATIENT WAS TRANSFERRED TO A HIGHER CARE FACILITY THE FOLLOWING WEEK. THE SYSTEM WAS REMOVED DUE TO POCKET INFECTION. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abscess; Erythema; Fever; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 21866613 ↗
• MalfunctionMar 20, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW IMPEDANCE. ADDITIONALLY, IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) APPEARED TO BE INTERMITTENTLY PACING INAPPROPRIATELY. THE LV LEAD AND CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655853 ↗
• InjuryMar 17, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE PATIENT REQUESTED THAT THE LV LEAD BE REMOVED. DURING THE LEAD EXPLANT PROCEDURE THE LV LEAD FRAGMENTED AND THE DISTAL PORTION OF THE LEAD WAS LEFT IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 21624657 ↗
• MalfunctionDec 30, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH DEFIBRILLATION IMPEDANCE. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE. 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 21043534 ↗
• InjuryDec 26, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PRESENTING ELECTROGRAMS (EGM) SHOWED FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND FAR FIELD OVERSENSING CAUSING INHIBITED PACING ON THE LEFT VENTRICULAR (LV) LEAD DESPITE PREVIOUS ADJUSTMENTS. THE LV LEAD WAS INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021094 ↗
• MalfunctionOct 7, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR HIGH DEFIBRILLATION IMPEDANCE. THE RV LEAD ALSO EXHIBITED LOW PACING IMPEDANCE. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUTPUTS. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY LONGEVITY WAS NOT AS LONG AS EXPECTED BY THE PATIENT. THE RV LEAD, 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 20387198 ↗
• MalfunctionSep 24, 2024Capturing Problem; Unstable Capture Threshold; Capturing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THERE WAS UNDERSENING ON THE RIGHT ATRIAL (RA) LEAD RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AND TRIGGERING INAPPROPRIATE ATRIAL PACING. IT WAS ALSO NOTED THERE WAS FLUCTUATION AND GRADUAL INCREASE IN LEFT VENTRICULAR (LV) LEAD THRESHOLD. 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 20291304 ↗
• InjuryAug 26, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A LOSS OF CAPTURE, AND THE DEVICE WAS REPROGRAMMED TO RIGHT VENTRICULAR (RV) ONLY PACING. APPROXIMATELY THREE MONTHS LATER, THE PATIENT WAS SEEN, AND TESTING NOTED GOOD CAPTURE IN A DIFFERENT VECTOR. THE LV LEAD WAS PROGRAMMED BACK ON 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 20066402 ↗
• InjuryAug 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LV LEAD WAS INACTIVATED AND REMAINS IN THE PATIENT. IT WAS NOTED THAT THE LEAD HAS BEEN INACTIVATED FOR MANY YEARS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20021989 ↗
• InjuryAug 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF DIZZINESS AND WAS LIGHTHEADED WITH THE LEFT VENTRICULAR (LV) 2 ¿ COIL VECTOR. FOLLOW-UP COMMUNICATION WITH THE CLINICIAN NOTED THAT THE PATIENT FAINTED AND EXPERIENCED SYNCOPE. EMERGENCY MEDICAL SERVICES NOTED THAT THE PATIENT HAD HYPOTENSION. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT AND WAS NOTED TO BE HYPERTENSIVE. THE PATIENT WAS TREATED WITH MULTIPLE FLUID BOLUSES AND THE LV LEAD VECTOR WAS REPROGRAMMED. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Syncope/Fainting

  MAUDE report 20019119 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTION WITH A HEMATOMA WAS NOTED APPROXIMATELY ONE MONTH POST GENERATOR CHANGE OUT. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19730840 ↗
• MalfunctionJun 13, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE CLINICIAN COULD NOT PROGRAM THE DEVICE INTO A MAGNETIC RESONANCE IMAGING (MRI) SCAN SAFE MODE AS THE LEFT V ENTRICULAR (LV) LEAD IMPEDANCE WAS OUT OF RANGE. 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 19529104 ↗