ATTAIN® PERFORMA™ S 459878Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00643169169036), received between Dec 9, 2016 and Aug 26, 2026 — classified as 3 deaths, 43 injuries, 28 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (25 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50457970 ↗
• 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 ↗
• InjuryJul 23, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD. 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 22582246 ↗
• MalfunctionJul 3, 2025Intermittent Capture; Unstable Capture Threshold; Intermittent Capture; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FLUCTUATING THRESHOLD OUTPUTS AND POTENTIAL INTERMITTENT LOSS OF CAPTURE EPISODES. 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 22398588 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD VISIBLY ERODED THROUGH THE SKIN AT THE DEVICE POCKET. THE POCKET SITE WAS SWABBED FOR INFECTION BUT THE SPECIFIC ORGANISM IS NOT KNOWN. THE CRT-D SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Pocket Erosion; Unspecified Infection

  MAUDE report 22178877 ↗
• InjuryApr 24, 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21901642 ↗
• MalfunctionMar 24, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT ELECTROCARDIOGRAM CHANGES WERE NOTED ON TELEMETRY AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21679189 ↗
• DeathFeb 7, 2025Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED, VIA FOLLOW UP, THE PATIENT HAD PREVIOUSLY PRESENTED WITH VENTRICULAR TACHYCARDIA (VT), NON-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI), AND CONGESTIVE HEART FAILURE WITH MULTIPLE APPROPRIATE SHOCKS IN THE EMERGENCY ROOM. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION/STENTING OF THE MID LEFT ANTERIOR DESCENDING (LAD) VEIN. THE PATIENT CONTINUED TO HAVE VT AND WAS TREATED WITH ANTI-ARRHYTHMIC MEDICATION AND TWO VT ABLATIONS, HOWEVER CONTINUED TO HAVE RECURRENT VT REQUIRING SHOCKS. A CODE WAS CALLED DUE TO VT AND ADVANCED CARDIAC LIFE SUPPORT WAS PROVIDED AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) BUT CONTINUED TO ARREST. ANOTHER CODE WAS CALLED, HOWEVER, THE PATIENT PASSED AWAY. IT WAS NOTED THAT LV LEAD CAPTURE WAS UNABLE TO BE MEASURED DUE TO COMPETING FAST RHYTHM AND WAS NOT A PRIMARY CONCERN FOR THE PHYSICIAN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21334603 ↗
• MalfunctionJan 16, 2025High Capture Threshold; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE ATP THERAPIES WERE APPROPRIATE. IT WAS ALSO NOTED THAT THE HIGH LV THRESHOLD WAS NOT CONFIRMED AND THERE WAS NORMAL LV THRESHOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173356 ↗
• MalfunctionJan 16, 2025Unstable Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FLUCTUATING PACING THRESHOLDS. THE LEAD REMAINS IN USE. NO PATIENT COM PLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172642 ↗
• InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION, WHICH WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. EROSION AND WOUND DEHISCENCE WERE ALSO OBSERVED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH AN LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 20918331 ↗
• InjuryOct 28, 2024Adverse 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 AN INFECTION. FEVER AND BACTEREMIA WERE ALSO NOTED. THE CRT-D, RIGHT ATRIAL (RA) LEAD, AND RIGHT VENTRICULAR (RV) LEAD WERE SUBSEQUENTLY REPLACED EIGHT DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Fever; Unspecified Infection

  MAUDE report 20545067 ↗
• MalfunctionOct 16, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE HIGH 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 20462113 ↗
• MalfunctionAug 5, 2024High Capture Threshold; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE PATIENT REPORTED FELT THEIR HEART "FLIP FLOPPING." SYMPTOMS ARE NOT A RESULT OF PRODUCT PERFORMANCE. THE PATIENT HAD SOME ATRIAL FIBRILLATION (AF) POST CORONARY ARTERY BYPASS GRAFT (CABG).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907524 ↗
• MalfunctionJul 24, 2024Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED VARIABLE R WAVE AND THRESHOLDS MEASUREMENTS. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD DISPLAYED A DECREASE IN PACING IMPEDANCE AND THRESHOLDS. THE RV LEAD WAS EXPLANTED AND REPLACED. ONE DAY AFTER THE REVISION, THE REPLACEMENT RV LEAD DISPLAYED AN INCREASE IN PACING IMPEDANCE. THE REPLACEMENT RV LEAD AND LV 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 19818954 ↗
• InjuryJun 18, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THERE WERE THE EFFECTIVE CARDIAC RESYNCHRONIZATION THERAPY PACING PERCENTAGE DROPPED DRAMATICALLY. IT WAS NOTED THAT THE EPISODES MAY BE INDICATIVE OF POSSIBLE LEFT VENTRICULAR (LV) LEAD AND RIGHT VENTRICULAR (RV) LEAD LOSS OF CAPTURE. THE LV AND RV 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 19562739 ↗
• MalfunctionMay 13, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLD HAD NOT BEEN MEASURED DUE TO COMPETING RHYTHMS. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE LEAD EXHIBITED A FAILURE TO CAPTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19298799 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCE ONE OF THEIR "LOWER LEADS INTERMITTENTLY PUMPING NEAR THEIR DIAPHRAGM WHICH CAUSES IT TO MOVE UP AND DOWN." THE PATIENT NOTED THAT REPROGRAMMING WAS PERFORMED AND FOUR DAYS FOLLOWING THE REPROGRAMMING, THE "PUMPING" SUBSEQUENTLY REOCCURRED. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 18022965 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED WITH A COMPETITOR DEVICE SYSTEM DUE TO A BACTEREMIA. APPROXIMATELY TWO WEEKS LATER, A REPLACEMENT SYSTEM WAS IMPLANTED. DURING THE PROCEDURE, THE REPLACEMENT LV LEAD FRACTURED AT THE PROXIMAL END WHILE THE SURGEON WAS TUNNELING THE LEAD. THE LV LEAD WAS REMOVED AND NOT USED. A REPLACEMENT LEAD WAS SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 17826002 ↗
• MalfunctionSep 20, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING USE OF THE LEFT VENTRICULAR (LV) LEAD, THE LV 4 ELECTRODE WAS NOTED WITH HIGH UNDEFINED IMPEDANCE.  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 17782059 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) GENERATOR REPLACEMENT WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT PRESENT TO THE EMERGENCY ROOM DUE TO WEAKNESS, FEVER AND EVIDENCE OF A URINARY TRACT INFECTION. BLOOD CULTURE GREW ENTEROCOCCUS FAECALIS AND THE PATIENT WAS ADMITTED. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DID NOT SHOW VEGETATIONS, HOWEVER, TWO DAYS LATER A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED MULTIPLE MOBILE ECHO DENSITIES ON THE RIGHTATRIAL (RA) LEAD. THE PATIENT WAS STARTED ON INTRAVENOUS ANTIBIOTICS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED SEVEN DAYS LATER DUE TO BACTEREMIA WITH A TEMPORARY TRANSVENOUS PACING PLACED. SEVEN DAYS LATER, THE PATIENT WAS CLEARED FOR REPLACEMENT BY INFECTIOUS DISEASE AND A NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS IMPLANTED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 17759053 ↗
• InjuryJun 6, 2023Adverse 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 AN INFECTION. THE CRT-D WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17074804 ↗
• MalfunctionMay 2, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH UNDEFINED IMPEDANCE ON ONE ELECTRODE. 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 16855999 ↗
• MalfunctionMar 28, 2023Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASING AND HIGH PACING THRESHOLDS. NO ACTION WAS TAKEN AND 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 16629707 ↗
• InjuryFeb 9, 2023Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS FURTHER REPORTED THE THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16335210 ↗