Attain Performa™ Straight MRI SureScan™ 439878Recalls & reported problems

Summary

The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 00643169601840), received between Dec 9, 2016 and Sep 11, 2026 — classified as 5 deaths, 219 injuries, 106 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (102 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 330 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that five months post implant, the Left Ventricular (LV) lead was explanted and replaced for unknown reasons. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736691 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the Left Ventricular (LV) lead and Right Ventricular (RV) lead explant procedure, a perforation was noted. It was also noted that the patient developed a pericardial effusion due to the LV lead and an emergency sternotomy was performed. The LV lead was successfully explanted and the RV lead was inactivated. No further patient complications have been reported as a result of this event.

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 50436696 ↗
• MalfunctionAug 12, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50223670 ↗
• MalfunctionJul 10, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25783042 ↗
• MalfunctionJun 15, 2026Capturing Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING 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 25505514 ↗
• InjuryJun 12, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR LOW PACING IMPEDANCE, THE MEASUREMENTS WERE CONSISTENT WITH HISTORICAL VALUES. THE LEFT VENTRICULAR (LV) LEAD HAD UNDEFINED HIGH PACING IMPEDANCE. IT WAS NOTED THAT THE LV LEAD HAD BEEN PROGRAMMED OFF AND REMAINS IMPLANTED. THE RV 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 25488476 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS REMOVED DUE TO POCKET EROSION AND LIKELY POCKET INFECTION. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 25260248 ↗
• DeathApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INTERMITTENT RIGHT VENTRICULAR (RV) LEAD UNDERSENSING OBSERVED ON STORED EPISODES. YEARS LATER IT WAS REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE. EMERGENCY MEDICAL SERVICES (EMS) PROVIDED CARDIOPULMONARY RESUSCITATION (CPR) AND TWO EXTERNAL SHOCKS TO THE PATIENT. UPON REVIEW THERE WAS ADDITIONAL UNDERSENSING AND OVERSENSING OBSERVED ON THE RV LEAD. VENTRICULAR TACHYCARDIA (VT) THERAPIES WERE NOT PREVIOUSLY PROGRAMMED ON AND WERE PROGRAMMED ON FOLLOWING THE EVENT. THE PATIENT DIED TWO DAYS LATER. IT WAS FURTHER REPORTED THAT SYSTEM PERFORMANCE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THE PATIENT¿S DEATH, HOWEVER CAUSE OF DEATH WAS NOTED TO BE SEPSIS AND CARDIAC ARREST. THE SOURCE OF THE INFECTION WAS REQUESTED BUT WAS UNKNOWN.

  Patient problems: Cardiac Arrest; Sepsis

  MAUDE report 24943729 ↗
• MalfunctionApr 20, 2026Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN UNNECESSARY PACING. 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 24927145 ↗
• InjuryApr 8, 2026Extracardiac stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING IN NON-PHYSIOLOGIC INTERVALS AND UNDERSENSING BEFORE VENTRICULAR FIBRILLATION (VF) DETECTION RESULTING IN DELAY OF EPISODE DETECTION. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS PREVIOUSLY REPROGRAMMED DUE TO PHRENIC STIMULATION. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 24817687 ↗
• InjuryApr 6, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR SKIN WAS ¿JUMPING A LITTLE BIT¿ AND HAD A ¿SMALL PAIN¿ IN THEIR CHEST SINCE. THE PATIENT NOTED THAT THEY HAVE A BLOOD CLOT IN THEIR LEFT CHAMBER THAT MIGHT BE CAUSING THEIR SYMPTOMS AND IS BEING TREATED WITH WARFARIN. THE PATIENT ALSO NOTED THAT THEY WERE EXPERIENCING PALPITATIONS AND SHORTNESS OF BREATH. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Pain; Palpitations; Thrombosis/Thrombus

  MAUDE report 24792752 ↗
• MalfunctionApr 3, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE VERSUS INEFFECTIVE PACING. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 24777766 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE SYSTEM WAS EXPLANTED AND REPLACED DUE TO POCKET EROSION. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED AND NOT CAPTURING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 24713673 ↗
• MalfunctionMar 17, 2026Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A GRADUAL INCREASE IN IMPEDANCE AND 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 24617280 ↗
• MalfunctionMar 9, 2026Failure to Capture; Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS NOTED ON LEAD TRENDS. IT WAS ALSO NOTED THAT THE LEAD EXHIBITED A POSSIBLE 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 24547022 ↗
• MalfunctionMar 6, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING CAPTURE THRESHOLDS AND 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 24533347 ↗
• InjuryMar 6, 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 NOTED AS ENDOCADITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis

  MAUDE report 24531475 ↗
• MalfunctionFeb 23, 2026Extracardiac stimulation; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS ON ALL VECTORS AND THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 24421740 ↗
• MalfunctionFeb 20, 2026Failure to Capture; Extracardiac stimulation

  IT WAS REPORTED THAT THERE WAS POSSIBLE LOSS OF LEFT VENTRICULAR (LV) LEAD CAPTURE ON DIAGNOSTIC EPISODES TO DETERMINE EFFECTIVE PACING. THERE WAS ALSO STIMULATION NOTED ON A LV VECTOR. THE 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 24400673 ↗
• MalfunctionFeb 17, 2026High Capture Threshold

  IT WAS REPORTED THAT THERE WAS INTERMITTENT UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD THAT RESULTED IN MISCLASSIFICATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). IN ADDITION, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. 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 24365160 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT EXPERIENCED AN STAPHYLOCOCCUS AUREUS INFECTION. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 24349975 ↗
• InjuryFeb 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED DISLODGMENT POST POCKET CLOSURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317302 ↗
• InjuryFeb 9, 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 24300479 ↗
• InjuryJan 22, 2026Break; Disconnection

  IT WAS REPORTED THAT DURING A ROUTINE GENERATOR REPLACEMENT PROCEDURE, WHEN THE PHYSICIAN WENT TO UNSCREW THE LEFT VENTRICULAR (LV) LEAD, THE INSULATION CAME OFF EXPOSING THE CONDUCTOR. IT WAS ALSO NOTED THAT THERE WAS A BROKEN CONNECTOR PIN. THE LV LEAD WAS 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 24145361 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUSPECTED BLOOD INFECTION. 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 24140987 ↗