NA 5071-25 (UDI 00681490124300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00681490124300), received between Dec 18, 2015 and Sep 25, 2024 — classified as 18 injuries, 6 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (12 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED SUSPECTED LOSS OF CAPTURE DURING MAGNET ELECTROGRAMS (EGM). 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 20298974 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MUSCLE STIMULATION WITH COMPLAINTS OF PULSING AROUND THEIR DEVICE.  THE RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED TO NO AVAIL AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 15385027 ↗
• InjuryFeb 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE EPICARDIAL LEFT VENTRICULAR (LV) LEAD FRACTURED. THE LEAD WAS CAPPED AND REPLACED WITH A TRANSVENOUS LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586601 ↗
• InjuryJan 25, 2022Break; Failure to Capture; High Capture Threshold; Break; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS LEADING TO NON CAPTURE. THIS RESULTED IN HIGHER DRAINAGE ON THE BATTERY ON THE IMPLANTABLE PULSE GENERATOR (IPG), RESULTING IN UNEXPECTED BATTERY LONGEVITY. THE RV LEAD ALSO EXHIBITED HIGH THRESHOLDS AND NON CAPTURE WHEN THE SETTINGS OF THE IPG REACTIVATED IT.  DURING THE CHANGE OUT PROCEDURE, THE PACING LEADS WERE DAMAGED AND WERE PARTIALLY REMOVED AND REPLACED. THE IPG WAS EXPLANTED AND REPLACED. THE IPG SET TO PACE RA LEAD ONLY AND HAVE THE RV LEAD INACTIVE UNTIL REQUIRED. TEMPORARY PACING WAS REQUIRED DURING THE GENERATOR PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13341178 ↗
• InjuryJan 19, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING THRESHOLDS. THE RV 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 13289588 ↗
• MalfunctionJan 4, 2021Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS EXHIBITED OVERSENSING OF SHORT V-V INTERNAL COUNTS AND CHRONICALLY HIGH THRESHOLDS. THE RIGHT VENTRICULAR (RV) 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 11109243 ↗
• InjuryDec 18, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) EPICARDIAL LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE ABDOMINAL, SINGLE CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED PREMATURE BATTERY DEPLETION POST TWO AND A HALF YEARS, DUE TO HIGH THRESHOLDS OF RV LEAD. BOTH THE RV LEAD AND THE ABDOMINAL IPG WERE INACTIVATED AND REPLACED WITH A LEADLESS IPG. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11037724 ↗
• InjuryDec 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FRACTURED. THE RV 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 11025904 ↗
• InjuryOct 27, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A LEAD FAILURE. THE DEVICE WAS REPROGRAMMED TO VVI PACING AND THE LEAD WAS SUBSEQUENTLY INACTIVATED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10739136 ↗
• InjuryOct 27, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEADS EXHIBITED ELEVATED THRESHOLDS. THE LEADS WERE SUBSEQUENTLY CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10739123 ↗
• InjuryAug 18, 2020Fracture; Over-Sensing; High Capture Threshold; Fracture; Over-Sensing; High Capture Threshold

  IT WAS FURTHER REPORTED THAT LEAD FRACTURES COULD NOT BE CONFIRMED. THE RV LEAD EXHIBITED OVERSENSING AND THE RA LEAD EXHIBITED ELEVATED THRESHOLDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419858 ↗
• InjuryJun 9, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEADS WERE DOUBLE COUNTING R-WAVES. THE LEADS WERE REPROGRAMMED AND CONTINUES TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135792 ↗
• InjuryJun 9, 2020Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEADS WERE DOUBLE COUNTING R-WAVES. THE LEADS WERE REPROGRAMMED AND CONTINUES TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135783 ↗
• InjuryApr 27, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT HIGH THRESHOLDS WERE NOTED ON THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10000758 ↗
• InjuryNov 4, 2019Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD "FOUR SETS OF LEADS REMOVED THAT WERE INFECTED AND FRACTURED". THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9272974 ↗
• InjuryNov 4, 2019Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD "FOUR SETS OF LEADS REMOVED THAT WERE INFECTED AND FRACTURED". THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9272964 ↗
• InjuryNov 1, 2019Fracture; Pacing Problem; Device Sensing Problem; Fracture; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD FRACTURED, AND IT WAS UNABLE TO PACE OR SENSE RELIABLY. THE RA LEAD WAS PROGRAMMED OFF. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9265923 ↗
• InjuryJun 6, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED WITH A LEADLESS PACEMAKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575474 ↗
• InjuryJun 6, 2018High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD. THE RV LEAD WAS CAPPED AND REPLACED WITH A LEADLESS PACEMAKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575453 ↗
• MalfunctionMay 15, 2018Low impedance; Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW IMPEDANCE. FOLLOW UP YIELDED NO INFORMATION. THE LV 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 7514611 ↗
• MalfunctionFeb 8, 2018Low impedance; High Capture Threshold; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS FURTHER NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY LONGEVITY ESTIMATOR MEASUREMENT WAS NOT AVAILABLE, HOWEVER, THE BATTERY VOLTAGE WAS AVAILABLE. THE DEVICE AND LEADS REMAIN 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 7255888 ↗
• MalfunctionFeb 8, 2018Low impedance; High Capture Threshold; Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS FURTHER NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) BATTERY LONGEVITY ESTIMATOR MEASUREMENT WAS NOT AVAILABLE, HOWEVER, THE BATTERY VOLTAGE WAS AVAILABLE. THE DEVICE AND LEADS REMAIN 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 7255866 ↗
• MalfunctionApr 6, 2017Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT A HEALTHCARE PROFESSIONAL (HCP) PHONED IN TO INQUIRE ABOUT POTENTIAL LEAD OPTIMIZATION OF THE PATIENTS RIGHT VENTRICULAR (RV) EPICARDIAL LEAD THAT WAS OVERSENSING, WHICH RESULTED IN DOUBLE-COUNTING R-WAVES. HIGH CAPTURE THRESHOLD WAS ALSO NOTED ON THE RV LEAD. PROGRAMMING OPTIONS WERE DISCUSSED, BUT IT IS UNCLEAR IF ANY PROGRAMMING OPTIMIZATION WAS COMPLETED. 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 6468582 ↗
• InjuryDec 18, 2015Failure to Capture; Device Sensing Problem

  IT WAS REPORTED THERE WAS NO CAPTURE ON THE ATRIAL LEAD WHEN SET AT MAXIMUM OUTPUT AND THERE WAS NO SENSING OF INTRINSIC ACTIVITY. IT WAS ALSO REPORTED THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH IMPEDANCE AND THERE WAS A CONFIRMED FRACTURE. THE LEADS WERE PARTIALLY REMOVED AND WERE REPLACED. IT WAS FURTHER REPORTED THERE WAS ¿TREMENDOUS DIFFICULTY FINDING VIABLE TISSUE¿ FOR PLACEMENT OF THE NEW ATRIAL LEAD. WHEN ELECTRICAL TESTING WAS PERFORMED ONLY P WAVES WERE OBTAINED AND THERE WAS NO CAPTURE AT MAXIMUM OUTPUT. THE PHYSICIANS DECIDED TO LEAVE THE LEAD IN USE. WHEN THE LEAD WAS TESTED POST-OPERATIVELY, THE ATRIAL LEAD DID NOT SENSE INTRINSIC P WAVES, BUT INSTEAD R WAVES. MARKER CHANNELS INDICATED ATRIAL SENSING OCCURRED SIMULTANEOUSLY WITH VENTRICULAR SENSING. THE PATIENT EXPERIENCED PAIN WHEN THE ATRIUM WAS PACED. THE PROGRAMMING MODE WAS CHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Pain; Undesired Nerve Stimulation

  MAUDE report 5312040 ↗