ATTAIN® PERFORMA™ STRAIGHT 439878Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00643169002487), received between Dec 9, 2016 and Feb 19, 2025 — classified as 28 injuries, 8 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (9 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 36 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2025Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED THAT THE LEAD WAS IDENTIFIED AS A LEFT VENTRICULAR (LV) LEAD THAT EXHIBITED NO CAPTURE. THE LV LEAD OUTPUT WAS INCREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21413776 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THERE WAS OVERSENSING AND NOISE NOTED ON THE STORED EPISODES. THE PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO THE LEAD NOISE. THE PATIENT ALSO EXPERIENCED PHRENIC NERVE STIMULATION LEFT VENTRICULAR (LV) LEAD POST OPERATIVELY. FOLLOW UP WAS CONDUCTED AND NOTED THAT THE CAUSE OF THE INAPPROPRIATE SHOCKS WAS DETERMINED TO BE DUE TO A TOTAL LEFT SHOULDER ARTHROPLASTY SURGERY AND WERE IN RESPONSE TO THE NOISE OBSERVED ON THE LEAD DURING THE PROCEDURE. IT WAS ALSO NOTED THAT LV LEAD IS PROGRAMMED OFF. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 21061326 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND LEFT VENTRICULAR (LV) LEAD WERE EXPLANTED AND REPLACED DUE TO INFECTION. REDNESS WAS ALSO NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 18654749 ↗
• MalfunctionDec 22, 2023Capturing Problem; Unstable Capture Threshold; Capturing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD EXHIBITED A RISE AND UNSTABLE PACING THRESHOLDS POST ABLATION WHICH RESULTED IN PERICARDITIS WHICH HAVE SINCE RESOLVED. 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 18380766 ↗
• MalfunctionSep 8, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE ON STORED EPISODES. THE LV LEAD REMAINS IN US E. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711662 ↗
• MalfunctionAug 15, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH 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 17552712 ↗
• MalfunctionMar 24, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD THAT CAUSED PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). FOLLOW UP CONCLUDED THAT NO INTERVENTION WAS PERFORMED AND THE DEVICE AND LEAD WILL CONTINUE TO BE MONITORED. THE DEVICE AND 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 16611743 ↗
• InjuryAug 11, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION.  IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND THE LEFT VENTRICULAR (LV) LEAD HAD EXHIBITED HIGH THRESHOLDS SINCE IMPLANT.  THE LV LEAD THRESHOLD SETTING WAS RE-PROGRAMMED.  THE RA 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 15209731 ↗
• MalfunctionJun 17, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH UNDEFINED IMPEDANCE IN ONLY ONE VECTOR.  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 14732870 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 14016157 ↗
• MalfunctionOct 18, 2021Impedance Problem; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE CRT-D HAD BEEN TURNED OFF AND THE PATIENT RECEIVED AN LEFT VENTRICULAR ASSIST DEVICE (LVAD).

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

  MAUDE report 12652693 ↗
• MalfunctionFeb 18, 2021Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS WITH POTENTIAL 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 11342717 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 11286128 ↗
• InjuryMar 21, 2020Fracture; High impedance; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Fracture; High impedance; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A GRADUAL RISE IN IMPEDANCE THAT WAS NOW HIGH AND A POSSIBLE FRACTURE. IT WAS ADDITIONALLY NOTED THAT THE PATIENT EXPERIENCED EXTRACARDIAC STIMULATION. THE LEAD WAS INITIALLY REPROGRAMMED AND LATER EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 9863370 ↗
• InjuryFeb 24, 2020Adverse 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 REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9745120 ↗
• InjuryOct 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD AT THE CURRENT VECTOR OF LV4 TO RIGHT VENTRICULAR (RV) COIL. IT WAS ALSO NOTED THAT VECTOR EXPRESS WAS SHOWING THAT THE "LV AND RV WERE TOO CLOSE TOGETHER". THE LV LEAD WAS REPROGRAMMED TO RESOLVE THE STIMULATION AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 9141967 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT, IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, EXPERIENCED BACTEREMIA. BLOOD CULTURES WERE POSITIVE FOR CARDIOBACTERIUM HOMINIS SECONDARY TO ENDOCARDITIS, FIBRIN STRANDS WERE NOTED ON THE RIGHT VENTRICULAR LEAD WITH TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE), AND INTRAVENOUS (IV) ANTIBIOTICS WERE NECESSARY, WHICH RESOLVED THE ISSUE. THE SYSTEM REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 8937198 ↗
• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SEPSIS, PNEUMONIA AND AN ALTERED MENTAL STATUS. VEGETATION WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE DEVICE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 8892574 ↗
• InjuryAug 2, 2019Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH FLUID BUILD-UP AND WAS FOUND TO HAVE BILATERAL ANKLE EDEMA WITH FATIGUE. THE PATIENT ADMITTED TO DIETARY INDISCRETION. IT WAS NOTED THE LEFT VENTRICULAR (LV) LEAD ADAPTED AMPLITUDE HAD INCREASED DUE TO LOSS OF CAPTURE. THE LV PACING VECTOR WAS REPROGRAMMED AND THE LV LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE ADAPT RESPONSE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Edema; Fatigue

  MAUDE report 8853849 ↗
• InjuryMar 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT LATERAL MID THORAX MUSCLE STIMULATION DUE TO THE LEFT VENTRICULAR LEAD. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE ADAPTRESPONSE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Muscle Stimulation

  MAUDE report 8440718 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT REACH EXPECTED LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND CAUSED DIAPHRAGMATIC STIMULATION. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 8413445 ↗
• InjuryJan 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROUTINE UPGRADE PROCEDURE FROM AN IMPLANTABLE PULSE GENERATOR (IPG) TO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT EXPERIENCED A CORONARY SINUS (CS) DISSECTION. THE LEFT VENTRICULAR LEAD WAS NOT USED AND ANOTHER WAS IMPLANTED ABOUT 18 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vascular Dissection

  MAUDE report 8276069 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT¿S SYSTEM WAS REMOVED DUE TO INFECTION. THE PATIENT DEVELOPED BACTEREMIA DUE TO (B)(6) WITH LEAD VEGETATION AND PRESENTED TO EMERGENCY ROOM (ER) WITH RIGHT BUTTOCK PAIN. THE PATIENT WAS TREATED FOR NECROTIZING FASCIITIS AND DEBRIDEMENT WAS PERFORMED. THE PATIENT IS ENROLLED IN THE ADAPT RESPONSE CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8237942 ↗
• MalfunctionOct 28, 2018Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD BEEN INCREASING AND IS NOW HIGH. FOLLOW UP YIELDED NO INFORMATION. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8011345 ↗
• InjuryJun 21, 2018Adverse 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 REMOVED DUE TO BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7624891 ↗