NA 5071-53 (UDI 00643169638600)Recalls & reported problems

Summary

The FDA's MAUDE database contains 304 adverse event reports that list this exact device (DI 00643169638600), received between Dec 9, 2016 and Sep 28, 2026 — classified as 2 deaths, 200 injuries, 102 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (144 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 304 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Over-Sensing; Pacing Problem; Under-Sensing

  It was reported that approximately two weeks post-implant the Right Atrial (RA) leads exhibited Far Field R-Wave (FFRW) oversensing and undersensing resulting in inappropriate pacing. Both RA 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 50914608 ↗
• MalfunctionSep 28, 2026Over-Sensing; Pacing Problem; Under-Sensing

  It was reported that approximately two weeks post-implant the Right Atrial (RA) leads exhibited Far Field R-Wave (FFRW) oversensing and under sensing resulting in inappropriate pacing. Both RA 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 50914597 ↗
• MalfunctionSep 17, 2026Failure to Capture; High Capture Threshold

  It was reported that the Right Atrial (RA) lead exhibited oversensing and noise. It was further noted that the Right Ventricular (RV) lead exhibited high thresholds and no capture. The RA and RV 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 50800359 ↗
• MalfunctionSep 17, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Atrial (RA) lead exhibited oversensing and noise. It was further noted that the Right Ventricular (RV) lead exhibited high thresholds and no capture. The RA and RV 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 50800320 ↗
• MalfunctionSep 1, 2026Signal Artifact/Noise; High impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50543091 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pocket erosion. The Implantable Pulse Generator (IPG), Right Ventricular (RV) lead, and Right Atrial (RA) lead were explanted and another RV lead was capped. The system was replaced with a leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Pocket Erosion

  MAUDE report 50476514 ↗
• MalfunctionAug 21, 2026Failure to Capture; Low impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50375557 ↗
• InjuryAug 20, 2026Signal Artifact/Noise

  It was reported that the patient experienced dizziness. It was further reported that the left ventricle epicardial lead exhibited noise. The Implantable Pulse Generator (IPG) system was removed and replaced with a Leadless IPG. No further patient complications have been reported as a result of this event.

  Patient problems: Dizziness

  MAUDE report 50340470 ↗
• MalfunctionAug 12, 2026Capturing Problem

  It was reported that there was a sudden increase in the Left Ventricular (LV) lead threshold trends from the patient's baseline measurements. 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 50223771 ↗
• MalfunctionAug 8, 2026Unstable Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited variable thresholds causing an unexpected drop in battery longevity. The RV lead and Cardiac Resynchronization Therapy Pacemaker (CRT-P) remain in use. No patient complications have been reported as aresult of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50186665 ↗
• InjuryAug 5, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient experienced shortness of breath. The Left Ventricular (LV) lead was capped and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Dyspnea

  MAUDE report 50143461 ↗
• DeathMay 6, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL LEADS EXHIBITED LOSS OF CAPTURE ON THE CURRENT ELECTROGRAMS (EGM), OVERSENSING WITH SENSED EVENTS NOTED POST VENTRICULAR BLANKING, AND OVERSENSING OF NOISE RESULTING IN INHIBITION OF PACING. IT WAS NOTED THAT THE PATIENT HAD AN ALTERED MENTAL STATUS AND WAS UNRESPONSIVE. IT WAS FURTHER REPORTED THAT APPROXIMATELY A MONTH PRIOR, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED ELECTROMAGNETIC INTERFERENCE FROM AN EXTERNAL, UNKNOWN SOURCE. THE CRT-D REMAINS IN USE. THE CRT-D AND RV EPICARDIAL LEADS REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Loss of consciousness; Stroke/CVA

  MAUDE report 25107701 ↗
• InjuryMay 1, 2026High Capture Threshold

  IT WAS REPORTED THAT BOTH LEFT VENTRICULAR (LV) LEADS EXHIBITED HIGH THRESHOLDS. THE LV LEADS WERE INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055340 ↗
• InjuryMay 1, 2026High Capture Threshold

  IT WAS REPORTED THAT BOTH LEFT VENTRICULAR (LV) LEADS EXHIBITED HIGH THRESHOLDS. THE LV LEADS WERE INACTIVATED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055317 ↗
• InjuryApr 11, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPERIENCED AND ALTERED STATE AND WAS UNABLE TO RESPOND. IT WAS NOTED THERE WAS A LOSS OF CAPTURE ON BOTH LEFT VENTRICULAR (LV) LEADS AND A RISE OF THRESHOLDS ON THE LV LEAD IN THE RIGHT ATRIAL (RA) LEAD PORT. THE LV LEADS WERE REPROGRAMMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 24851710 ↗
• InjuryApr 10, 2026Failure to Capture; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN EXPERIENCED AND ALTERED STATE AND WAS UNABLE TO RESPOND. IT WAS NOTED THERE WAS A LOSS OF CAPTURE ON BOTH LEFT VENTRICULAR (LV) LEADS  AND A RISE OF THRESHOLDS ON THE LV LEAD IN THE RIGHT ATRIAL (RA) LEAD PORT. THE LV LEADS WERE REPROGRAMMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 24839021 ↗
• MalfunctionApr 3, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEADS HAD HISTORICALLY TRIGGERED AN ALERT FOR HIGH 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 24778161 ↗
• MalfunctionApr 3, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEADS HAD HISTORICALLY TRIGGERED AN ALERT FOR HIGH 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 24778152 ↗
• DeathMar 26, 2026Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL LEAD EXHIBITED LOSS OF CAPTURE ON THE CURRENT ELECTROGRAMS (EGM), OVERSENSING WITH SENSED EVENTS NOTED POST VENTRICULAR BLANKING, AND OVERSENSING OF NOISE RESULTING IN INHIBITION OF PACING. IT WAS NOTED THAT THE PATIENT HAD AN ALTERED MENTAL STATUS AND WAS UNRESPONSIVE. THE RV EPICARDIAL LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Loss of consciousness; Stroke/CVA

  MAUDE report 24700200 ↗
• MalfunctionMar 12, 2026Over-Sensing; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE CHRONIC HIGH THRESHOLDS WERE OBSERVED PRIOR TO DEVICE CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24581514 ↗
• InjuryMar 11, 2026Failure to Capture; Low impedance; Capturing Problem; Device Sensing Problem

  IT WAS REPORTED THAT BOTH EPICARDIAL RIGHT VENTRICULAR (RV) LEADS EXHIBITED OUT OF RANGE LOW IMPEDANCE AND NO CAPTURE. THE LEADS ARE  CONNECTED TOGETHER BY AN ADAPTOR. BOTH 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 24568038 ↗
• MalfunctionJan 30, 2026Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED 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 24226872 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SIX MONTHS AFTER IMPLANT OF A MYOCARDIAL LEAD, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BEGAN TO ERODE THROUGH THE PATIENT'S SKIN, AND THE PATIENT EXPERIENCED DISCOMFORT AND REDNESS. THE CRTD SYSTEM WAS EXPLANTED AND NOT REPLACED, WITH EXCEPTION OF THE MYOCARDIAL LEAD, WHICH WAS CUT AND ALLOWED TO RETRACT BACK INTO THE PATIENT'S BODY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema

  MAUDE report 23860237 ↗
• InjuryDec 18, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED AND REPLACED DUE TO NON-CAPTURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845066 ↗
• InjuryNov 26, 2025Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE. IT WAS NOTED THAT THE LV LEAD HAD DISLODGED. THE LV LEAD WAS REPOSITIONED AND 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 23655128 ↗