ATTAIN OTWRecalls & reported problems across all models

We found 2 models of ATTAIN OTW by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 87 adverse event reports in the FDA's MAUDE database, received between Aug 8, 2014 and Aug 5, 2026 — classified as 67 injuries, 20 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (31 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 OTW problems

ATTAIN OTW models

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

• ATTAIN® OTW 419388

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  69 reports
• ATTAIN® OTW 419378

  permanent pacemaker Electrode
  18 reports

Recent ATTAIN OTW adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Fracture; High impedance; Capturing Problem; Impedance Problem; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead had fractured. Lead impedance had risen to a high undefined range and capture thresholds had risen to a high range. The 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 50143906 ↗
• InjuryJul 29, 2026Intermittent Capture; Capturing Problem; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited  high and rising LV threshold ad intermittent LV capture. The 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 50074721 ↗
• InjuryMay 28, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH RV COIL IMPEDANCE AND HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE.  IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NO CAPTURE.  ADDITIONALLY, IT WAS REPORTED THAT THE RV PACE/SENSE LEAD EXHIBITED RISING THRESHOLDS.  THE RV LEAD, LV LEAD AND RV PACE/SENSE LEAD WERE EXPLANTED.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25320219 ↗
• InjuryFeb 17, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE, UNDEFINED DEFIBRILLATION IMPEDANCE AND INCREASING THRESHOLDS AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT-OF-RANGE, LOW PACING IMPEDANCE. THE LEADS WERE EXTRACTED AND REIMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369647 ↗
• InjuryJan 23, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THAT THE PACE/SENSE RIGHT VENTRICULAR (RV) LEAD HAD LOW PACING IMPEDANCE, HIGH THRESHOLDS WITH NO CAPTURE AND THE INABILITY TO SENSE APPROPRIATELY. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS WITH LOSS OF CAPTURE. THE PATIENT WAS HOSPITALIZED. THE PACE/SENSE RV LEAD WAS TAKEN OUT OF SERVICE AND THE 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 24162390 ↗
• MalfunctionDec 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT A LEAD IS ¿NOT FUNCTIONING APPROPRIATELY.¿ THE LEFT VENTRICULAR (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 23871187 ↗
• InjuryOct 24, 2025Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH IMPEDANCE, HIGH THRESHOLDS AND NO CAPTURE. 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 23384995 ↗
• MalfunctionOct 20, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOW AND DECREASING IMPEDANCE. IT WAS FURTHER REPORTED THAT APPROXIMATELY SIX YEARS LATER, THE RA LEAD EXHIBITED LOW IMPEDANCE IN ADDITION TO UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES AND ALSO APPEARED TO RESULT IN INAPPROPRIATE ATRIAL PACING. THE PATIENT¿S LEFT VENTRICULAR (LV) TRIGGERED SEVERAL ALERTS FOR UNDEFINED HIGH PACING IMPEDANCE. 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 23342507 ↗
• InjuryJul 7, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH PACING THRESHOLDS. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED WITH A LEFT BUNDLE BRANCH AREA PACING LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413958 ↗
• InjuryApr 18, 2025Adverse 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 PROGRAMMED OFF DUE TO DIAPHRAGMATIC STIMULATION THAT COULD NOT BE PROGRAMMED AROUND. APPROXIMATELY 13 YEAR LATER, THE LV LEAD WAS CAPPED AND UNUSABLE. THE LEAD WAS ULTIMATELY EXPLANTED APPROXIMATELY 4 YEARS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 21868366 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LESS THAN 1 MONTH POST ROUTINE GENERATOR REPLACEMENT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION AND EROSION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED UNTIL A NEW CRT-D SYSTEM WAS IMPLANTED 15 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 21697366 ↗
• InjuryJan 23, 2025High impedance; Low impedance; Capturing Problem; Impedance Problem; High impedance; Low impedance; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING IMPEDANCE THAT WAS ALSO FLUCTUATING BETWEEN HIGH AND LOW. PACING THRESHOLDS WERE ALSO NOTED TO HAVE INCREASED OVER TIME. 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 21221261 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION WITH EVIDENCE OF VEGETATION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21116218 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS AFTER A GENERATOR CHANGEOUT PROCEDURE, WOUND DEHISCENCE AND DRAINAGE WERE NOTED AT THE INCISION SITE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. A POCKET INFECTION WAS NOTED WHICH REQUIRED A POCKET REVISION PROCEDURE. THE PATIENT EXPERIENCED DISCOMFORT AND EROSION AS A RESULT. INTRAVENOUS (IV) AND TOPICAL ANTIBIOTICS WERE ADMINISTERED AS WELL AS PAIN MEDICATION. THE CRT-D SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 20759125 ↗
• InjuryNov 5, 2024High impedance; High impedance

  IT WAS LATER REPORTED THAT THE LV LEAD WAS PROGRAMMED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611258 ↗

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