ATTAIN® PERFORMA™ STRAIGHT 439888Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00643169002517), received between Jun 9, 2016 and Sep 14, 2026 — classified as 1 death, 101 injuries, 49 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (59 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 151 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50752739 ↗
• MalfunctionJun 15, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING IN NON-PHYSIOLOGIC INTERVALS. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD CAPTURE THRESHOLD WAS HIGHER THAN THE PROGRAMMED OUTPUT. THE 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 25505745 ↗
• InjuryJun 11, 2026Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS WHICH RESULTING IN PREMATURE BATTERY DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS ALSO NOTED THAT THE LV LEAD EXHIBITED LOW IMPEDANCE. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE AND THE CRT-D 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 25474257 ↗
• InjuryApr 1, 2026Retraction Problem; Positioning Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS MALPOSITIONED AND NONFUNCTIONAL. IN ADDITION, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. DURING THE REVISION PROCEDURE; IT WAS DETERMINED TO REPLACE THE LV LEAD WITH AN EPICARDIAL LEAD. DURING ATTEMPTED EXTRACTION; SIGNIFICANT SCAR TISSUE WAS NOTED ON THE LV LEAD. THE LV LEAD COULD NOT BE EXTRACTED. THE LV LEAD WAS CAPPED AND REPLACED. IN ADDITION, THE CRT-D HEADER WAS INCOMPATIBLE WITH THE EPICARDIAL LEAD. THE CRT-D 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 24755959 ↗
• InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE 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 24663845 ↗
• InjuryNov 17, 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) DEVICE 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 23571102 ↗
• InjurySep 18, 2025Failure to Capture; Capturing Problem; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Failure to Capture; Capturing Problem; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS PHRENIC NERVE STIMULATION, DIAPHRAGMATIC STIMULATION, INCREASED THRESHOLD, AND NO CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD. THERE WAS ALSO T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEADS WERE REPROGRAMMED AND 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 23084375 ↗
• InjurySep 8, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED ELEVATED AND HIGH THRESHOLDS. 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 22996351 ↗
• InjuryAug 8, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED ELEVATED THRESHOLDS AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE LEAD WAS CAPPED AND REPLACED, AND THE CRT-D 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 22755522 ↗
• InjuryJul 23, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLD WAS ABOVE THE PROGRAMMED OUTPUT AT TIMES. 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 22576949 ↗
• MalfunctionJul 9, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-D WAS EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. 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 22465497 ↗
• InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MILD EDEMA, ERYTHEMA, SWELLING, INTERMITTENT PAIN, AND WARMTH AROUND THE DEVICE SITE DUE TO A POCKET INFECTION. THE PATIENT WAS TREATED WITH ORAL AND INTRAVENOUS ANTIBIOTICS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. THE PATIENT NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21963807 ↗
• InjuryApr 2, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THERE WAS LOW IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. TROUBLESHOOTING WAS PERFORMED TO OBTAIN A HIGHER IMPEDANCE, HOWEVER, IT WAS UNSUCCESSFUL. 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 21751667 ↗
• MalfunctionApr 1, 2025Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT DURING USE THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A DROP IN LV LEAD IMPEDANCE NOTED IN THE LEAD TREND, CURRENT MEASUREMENTS ARE WITHIN EXPECTED RANGE. THE LV LEAD REMAINS IN USE. IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF A THRESHOLD VALUE WHEN THE DEVICE FEATURE THAT AUTOMATICALLY MONITORS PACING THRESHOLDS AT PERIOD INTERVALS IS OFF OR IN MONITOR MODE. THE CRT-D 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 21745499 ↗
• DeathMar 31, 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) BECAME INFECTED. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Medical device site infection

  MAUDE report 21733570 ↗
• InjuryMar 26, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD THAT RESULTED IN PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CRT-D WAS EXPLANTED AND REPLACED. THE LV LEAD WAS REPROGRAMMED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21697036 ↗
• InjuryJan 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 A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21229536 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 20869912 ↗
• MalfunctionNov 20, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR ELEVATED SHORT V-V INTERVALS AND HIGH-RATE NON-SUSTAINED EPISODES. IT WAS FURTHER REPORTED THAT THE RV LEAD OVERSENSING AND NOISE HAS RESULTED IN INAPPROPRIATE SHOCKS. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD AND LV LEAD 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 20737320 ↗
• InjuryOct 14, 2024Adverse 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 GOING TO BE REVISED TO HELP IMPROVE THE QRS COMPLEX DURATION DURING A DEVICE CHANGEOUT PROCEDURE AS THE DEVICE WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). HOWEVER, THE VEIN WAS OCCLUDED SO THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 20446628 ↗
• MalfunctionOct 14, 2024Failure to Capture; Failure to Capture

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS RECHECKED APPROXIMATELY THREE WEEKS LATER, AND WAS NOTED TO BE IN ATRIAL FIBRILLATION (AF). THE PHYSICIAN REQUESTED DEVICE STAY IN THE PROGRAMMED MODE, NO ACTION TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446447 ↗
• InjurySep 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 WITH EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AS A RESULT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 20200230 ↗
• InjuryAug 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LV 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 20048732 ↗
• MalfunctionJul 23, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED ELEVATED THRESHOLDS. THE LV 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19806639 ↗
• InjuryMar 23, 2024Adverse 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 PATIENT EXPERIENCED DIAPHRAGMATIC. AND PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. ELEVATED THRESHOLDS WERE ALSO NOTED, ON THE LEAD. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED, AS A RESULT OF THIS EVENT. THE LV LEAD WAS TURNED OFF, PRIOR TO REPLACEMENT.

  Patient problems: Device Overstimulation of Tissue; Undesired Nerve Stimulation

  MAUDE report 18966390 ↗