ATTAIN PERFORMA STRAIGHTRecalls & reported problems across all models

We found 2 models of ATTAIN PERFORMA STRAIGHT by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 187 adverse event reports in the FDA's MAUDE database, received between Jun 9, 2016 and Sep 14, 2026 — classified as 1 death, 129 injuries, 57 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (68 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ATTAIN PERFORMA STRAIGHT problems

ATTAIN PERFORMA STRAIGHT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ATTAIN® PERFORMA™ STRAIGHT 439888

  permanent pacemaker Electrode
  1 death151 reports
• ATTAIN® PERFORMA™ STRAIGHT 439878

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  36 reports

Recent ATTAIN PERFORMA STRAIGHT adverse event reports

The 15 most recent reports across all models, 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 ↗

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