NA 6721M-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00681490148771), received between Feb 9, 2017 and Sep 24, 2026 — classified as 31 injuries, 25 malfunctions.

The most frequently reported specific device problem is “High impedance” (17 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Low impedance

  It was reported that the Epicardial Leads triggered alerts due to low, out-of-range Right Ventricular (RV) defibrillation impedance and Superior Vena Cava (SVC) defibrillation 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 50883711 ↗
• InjuryMay 22, 2026High impedance; Extracardiac stimulation; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED DEFIBRILLATION IMPEDANCE, HIGH THRESHOLDS, AND EXTRACARDIAC STIMULATION AFTER DEVICE CHANGE OUT. REPROGRAMMING WAS DONE TO TURN OFF HIGH VOLTAGE THERAPY, AND THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25260268 ↗
• MalfunctionMay 15, 2026High impedance

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE-NON-SUSTAINED EPISODE'S AND SENSING INTEGRITY COUNTER (SIC) IN ADDITION TO HIGH THRESHOLD AND T-WAVE OVERSENSING (TWOS) RESULTING IN INHIBITION OF PACING; POST DEVICE DEFIBRILLATION. IT WAS FURTHER REPORTED THAT THE EPICARDIAL RV DEFIBRILLATOR LEAD EXHIBITED OUT OF RANGE (OOR) HIGH 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 25194494 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. DURING THE PROCEDURE; AFTER REMOVAL OF THE ANTERIOR EPICARDIAL RIGHT VENTRICULAR (RV) PATCH LEAD, THE PHYSICIAN HAD TO CLOSE A HOLE LEFT BY THE RV ANTERIOR PATCH LEAD. THE OTHER EPICARDIAL LEFT VENTRICULAR (LV) PATCH LEAD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Medical device site infection

  MAUDE report 24630052 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. DURING THE PROCEDURE; AFTER REMOVAL OF THE ANTERIOR EPICARDIAL RIGHT VENTRICULAR (RV) PATCH LEAD, THE PHYSICIAN HAD TO CLOSE A HOLE LEFT BY THE RV ANTERIOR PATCH LEAD. THE OTHER EPICARDIAL LEFT VENTRICULAR (LV) PATCH LEAD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24627460 ↗
• MalfunctionMay 14, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL PATCH LEAD EXHIBITED OUT OF RANGE (OOR) HIGH DEFIB IMPEDANCE. THE 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 22018865 ↗
• InjuryApr 19, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL DEFIBRILLATION LEAD AND THE SUPERIOR VENA CAVA (SVC) EPICARDIAL DEFIBRILLATION LEAD BOTH HAD HIGH/UNDEFINED IMPEDANCES. THE RV EPICARDIAL DEFIBRILLATION LEAD WAS FRACTURED, THEREFORE, THE RV LEAD PORT POSITION IN THE DEVICE HEADER WAS CHANGED. THE RV LEAD WAS PLACED IN THE SVC PORT AND CAPPED. THE SVC LEAD WAS PLACED IN THE RV PORT 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 19146546 ↗
• InjuryMar 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL PATCH, LEFT VENTRICULAR (LV) EPICARDIAL PATCH, AND RV LEAD WERE ABANDONED DUE TO A POTENTIAL PRODUCT PERFORMANCE ISSUE. A NEW RV LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18996356 ↗
• InjuryMar 21, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE PATIENT'S TWO UNIPOLAR MYOCARDIAL SCREW-IN LEADS LOCATED IN THE RIGHT VENTRICLE EXHIBITED HIGH THRESHOLDS. THE LEADS WERE CAPPED AND REPLACED. IN ADDITION, THE PATIENT'S EPICARDIAL TRANSVENOUS LEAD EXPERIENCED OUT OF RANGE (OOR) IMPEDANCERESULTING FROM A SUSPECTED HIGH VOLTAGE FRACTURE. THE EPICARDIAL 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 18950713 ↗
• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A SUSPECTED INFECTION WI TH PURULENT DISCHARGE/PUS OBSERVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 18103657 ↗
• MalfunctionOct 20, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD INTERMITTENT T-WAVE OVERSENSING (TWOS) OBSERVED ON CURRENT ELECTROGRAM (EGM).  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 17975749 ↗
• MalfunctionSep 11, 2023High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAS HIGH VARIABLE THRESHOLDS. 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 17720093 ↗
• MalfunctionAug 3, 2023High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED ( HR-NS) AND SENSING INTEGRITY COUNTER (SIC) EPISODES. THE LEAD HAS OVERSENSING NOTED ON STORED ELECTROGRAMS. THE LEAD WAS NOTED TO HAVE T-WAVE OVERSENSING (TWOS). THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) DEFIBRILLATOR LEAD HAS AN ABRUPT INCREASING HIGH IMPEDANCE. THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE EPICARDIAL RIGHT ATRIAL (RA) LEAD HAS OVERSENSING SEEN ON STORED ELECTROGRAMS. 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 17452983 ↗
• InjuryJun 8, 2023High impedance; High impedance

  IT WAS FURTHER REPORTED THAT THE LEAD WAS REVISED AND CAPPED. A NEW LEAD WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087143 ↗
• InjuryApr 14, 2023Signal Artifact/Noise; Fracture; Over-Sensing; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Fracture; Over-Sensing; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS FURTHER REPORTED THAT ADDITIONAL REVIEW OF THE DEVICE DATA INDICATED THAT THE REDUCED-ENERGY SHOCKS MAY HAVE BEEN RELATED TO A COMPROMISED LEAD OR THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD REMAINS IN USE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 16742430 ↗
• MalfunctionSep 26, 2022Low impedance; Impedance Problem; High Capture Threshold; Low impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT REVIEW OF A REMOTE TRANSMISSION SHOWED THAT A WEEK POST-IMPLANT OF THE RIGHT ATRIAL (RA) LEAD, THE MEASURED P-WAVE AMPLITUDE HAD INCREASED SINCE IMPLANT, HOWEVER ONE DAY OF LOW P-WAVE AMPLITUDES WAS NOTED. THE TRANSMISSION ALSO SHOWED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS WHICH TRIGGERED AN ALERT AND APPEARED TO BE A CHRONIC KNOWN ISSUE. AN OBSERVATION FOR LOW OUT OF RANGE (OOR) RV PACING IMPEDANCE WAS TRIGGERED THREE DAYS POST-IMPLANT OF THE RA LEAD, HOWEVER PACING IMPEDANCE VALUES FOR THE PATIENT ALSO APPEARED TO BE CHRONICALLY LOW. IT WAS ALSO NOTED THAT THERE WAS A SLIGHT DECREASE IN RV DEFIBRILLATION IMPEDANCE OBSERVED FOLLOWING DEFIBRILLATION THRESHOLDS TESTING. 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 15485492 ↗
• MalfunctionDec 1, 2021Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT AN ALERT TRIGGERED DUE TO RIGHT VENTRICULAR (RV) DEFIBRILLATOR IMPEDANCES BELOW THE THRESHOLD. IN ADDITION, THE RV DEFIBRILLATOR AND SUPERIOR VENA CAVA (SVC) IMPEDANCE VALUES HAVE DECREASED SINCE IMPLANT. THE 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 12911467 ↗
• MalfunctionDec 1, 2021Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT AN ALERT TRIGGERED DUE TO RIGHT VENTRICULAR (RV) DEFIBRILLATOR IMPEDANCES BELOW THE THRESHOLD. IN ADDITION, THE RV DEFIBRILLATOR AND SUPERIOR VENA CAVA (SVC) IMPEDANCE VALUES HAVE DECREASED SINCE IMPLANT. THE 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 12911417 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO CONVERT FROM AN EPICARDIAL SYSTEM TO A TRANSVENOUS SYSTEM, A MILKY SUBSTANCE WAS OBSERVED IN THE DEVICE POCKET. THE DEVICE WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) EPICARDIAL LEADS WERE CAPPED. DRAINS WERE PLACED AND A LEADLESS PACEMAKER WAS IMPLANTED FOR PACING SUPPORT. AFTER CULTURES CONFIRMED AN INFECTION, THE EPICARDIAL LEADS WERE LATER FULLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12667901 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO CONVERT FROM AN EPICARDIAL SYSTEM TO A TRANSVENOUS SYSTEM, A MILKY SUBSTANCE WAS OBSERVED IN THE DEVICE POCKET. THE DEVICE WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LEFT VENTRICULAR (LV) EPICARDIAL LEADS WERE CAPPED. DRAINS WERE PLACED AND A LEADLESS PACEMAKER WAS IMPLANTED FOR PACING SUPPORT. AFTER CULTURES CONFIRMED AN INFECTION, THE EPICARDIAL LEADS WERE LATER FULLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12667744 ↗
• InjuryOct 4, 2021Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND HIGH/UNDEFINED SVC IMPEDANCE. THE LEAD IS SUSPECTED TO BE FRACTURED. 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 12572684 ↗
• InjuryJul 1, 2021Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THERE WAS A SUSPECTED LEAD ISSUE WITH THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD/PATCH AS THERE WAS A SPIKE TO UNDEFINED HIGH RV COIL IMPEDANCE AND A FRACTURE WAS POSSIBLE. THE SUPERIOR VENA CAVA (SVC) COIL OF THE OTHER RV LEAD HAD A SPIKE TO UNDEFINED HIGH IMPEDANCES AND A FRACTURE WAS NOTED TO BE POSSIBLE. IN ADDITION, THERE WAS VARIABLE IMPEDANCE NOTED FOR BOTH LEADS. THE EPICARDIAL RV LEAD/PATCH WAS CAPPED. THE RV 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 12100521 ↗
• InjuryJun 4, 2021Break; Over-Sensing; Break; Over-Sensing

  IT WAS REPORTED THAT DURING A PROCEDURE THE SURGEON NOTED THE HIGH VOLTAGE RIGHT VENTRICULAR (RV) LEAD HAD A LARGE INSULATION ABRASION. THE HIGH VOLTAGE 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 11938530 ↗
• MalfunctionMay 6, 2021Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS POTENTIAL UNDERSENSING NOTED FROM THE RIGHT VENTRICULAR (RV) LEAD DURING A TREATED VENTRICULAR EPISODE. ADDITIONAL INFORMATION REPORTED THE PATIENT IS DECEASED AND DIED IN A MANNER UNRELATED TO THE DEVICE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11784719 ↗
• MalfunctionMar 12, 2021Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING VARYING IMPEDANCES ON THE RV DEFIBRILLATION COIL. 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 11474085 ↗