NA 6721S-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00681490148818), received between Dec 9, 2016 and Sep 24, 2026 — classified as 1 death, 14 injuries, 11 malfunctions.

The most frequently reported specific device problem is “High impedance” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 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 50883669 ↗
• InjuryJul 10, 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) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE DEVICE SYSTEM WAS REPLACED SIX DAYS LATER ON THE LEFT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 22472656 ↗
• InjuryJul 10, 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) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE DEVICE SYSTEM WAS REPLACED SIX DAYS LATER ON THE LEFT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 22472654 ↗
• DeathFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTERIAL POCKET INFECTION REQUIRING ANTIBIOTICS. ADDITIONALLY, THE PATIENT UNDERWENT A IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET DEBRIDEMENT SURGERY. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED SEPSIS LEADING TO SEPTIC SHOCK. THE PATIENT PASSED AWAY.

  Patient problems: Sepsis; Septic Shock

  MAUDE report 21379508 ↗
• MalfunctionApr 23, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, AND THAT LEAD IMPEDANCE WARNINGS HAD TRIGGERED. THERE WERE IMPEDANCE JUMPS TO HIGH/UNDEFINED IMPEDANCE ON THE RIGHT VENTRICULAR (RV) COIL AND SUPERIOR VENA CAVA (SVC) COIL. IN ADDITION, THERE WAS A JUMP IN THE RV PACING IMPEDANCE. A REVIEW BY QUALIFIED PERSONNEL DETERMINED THAT THE RV EPICARDIAL PATCH WAS LIKELY FRACTURED. A FOLLOW-UP INVESTIGATION NOTED THAT THE PHYSICIAN WAS AWARE OF THE ISSUE. THE PATIENT AND FAMILY WERE ALSO AWARE OF A PREVIOUS INCIDENT THAT HAD RESULTED IN THE FRACTURE. THE DEVICE WAS INTERROGATED AND THE ALERTS STOPPED. THE RV LEAD AND DEFIBRILLATOR EPICARDIAL PATCHES 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 19168651 ↗
• MalfunctionApr 23, 2024Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, AND THAT LEAD IMPEDANCE WARNINGS HAD TRIGGERED. THERE WERE IMPEDANCE JUMPS TO HIGH/UNDEFINED IMPEDANCE ON THE RIGHT VENTRICULAR (RV) COIL AND SUPERIOR VENA CAVA (SVC) COIL. IN ADDITION, THERE WAS A JUMP IN THE RV PACING IMPEDANCE. A REVIEW BY QUALIFIED PERSONNEL DETERMINED THAT THE RV EPICARDIAL PATCH WAS LIKELY FRACTURED. A FOLLOW-UP INVESTIGATION NOTED THAT THE PHYSICIAN WAS AWARE OF THE ISSUE. THE PATIENT AND FAMILY WERE ALSO AWARE OF A PREVIOUS INCIDENT THAT HAD RESULTED IN THE FRACTURE. THE DEVICE WAS INTERROGATED AND THE ALERTS STOPPED. THE RV LEAD AND DEFIBRILLATOR EPICARDIAL PATCHES 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 19168627 ↗
• InjuryApr 19, 2024High impedance; 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 19146683 ↗
• MalfunctionDec 15, 2023High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT DURING USE THE RIGHT VENTRICULAR (RV) LEAD , SUPERIOR VENA CAVA (SVC) COIL EXHIBITED VARYING IMPEDANCE MEASUREMENTS.  ADDITIONALLY, AN ALERT ALSO TRIGGERED FOR THE RV LEAD , SVC COIL IMPEDANCE THAT WAS HIGHER THAN THE PROGRAMMED IMPEDANCE THRESHOLD.  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 18336230 ↗
• MalfunctionOct 18, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT THERE WAS AN ALERT ON THE RIGHT VENTRICULAR (RV) LEAD FOR LOW DEFIBRILLATION IMPEDANCE. 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 15626121 ↗
• MalfunctionJun 22, 2022Low impedance; Device Sensing Problem; Low impedance; Device Sensing Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST-IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR OUT OF RANGE (OOR) LOW DEFIBRILLATION IMPEDANCE. ALERTS WERE ALSO TRIGGERED FOR HIGH RV THRESHOLDS AND HIGH RIGHT ATRIAL (RA) LEAD THRESHOLDS. IT WAS FURTHER REPORTED THAT THERE WAS POTENTIAL ATRIAL UNDERSENSING, AND ONE VENTRICULAR SENSING EPISODE WAS NOTED. 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 14774645 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF HAVING A SKIN BOIL ABOVE WHERE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IMPLANTED. THE PATIENT WAS INITIALLY TREATED WITH INTRAVENOUS ANTIBIOTICS. THE ICD SYSTEM WAS THEN REMOVED DUE TO INFECTION. THE PATIENT WAS PROVIDED WITH LIFEVEST BEFORE BEING DISCHARGED HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Skin Inflammation; Unspecified Infection

  MAUDE report 10782166 ↗
• InjurySep 16, 2020Low impedance; Low impedance

  IT WAS FURTHER REPORTED THAT THE ICD PATCH MALPOSITION WAS CAUSING CARDIAC COMPRESSION AND LEFT VENTRICULAR DISTORTION INCLUDING LEFT VENTRICULAR TAMPONADE. THE PATCH WAS REPOSITIONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; No Consequences Or Impact To Patient

  MAUDE report 10541309 ↗
• InjurySep 16, 2020Low impedance; Low impedance

  IT WAS FURTHER REPORTED THAT THE ICD PATCH MALPOSITION WAS CAUSING CARDIAC COMPRESSION AND LEFT VENTRICULAR DISTORTION INCLUDING LEFT VENTRICULAR TAMPONADE. THE PATCH WAS REPOSITIONED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Tamponade; No Consequences Or Impact To Patient

  MAUDE report 10541306 ↗
• MalfunctionJul 31, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT ALERTS WERE TRIGGERED DUE TO LOW IMPEDANCE ON THE SVC COIL AND RV COIL OF THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEADS. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10349766 ↗
• InjuryJul 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE EPICARDIAL HIGH VOLTAGE LEAD PATCHES HAD CONFIRMED FRACTURES. THE LEADS WERE PROGRAMMED OFF. THE LEADS WERE CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10216941 ↗
• InjuryJul 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE EPICARDIAL HIGH VOLTAGE LEAD PATCHES HAD CONFIRMED FRACTURES. THE LEADS WERE PROGRAMMED OFF. THE LEADS WERE CAPPED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10216936 ↗
• MalfunctionApr 29, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIGH VOLTAGE EPICARDIAL LEAD PATCHES HAS HIGH IMPEDANCE. THE LEAD PATCHES WILL BE REVISED AT FUTURE DATE THAT HAS NOT BEEN SET. THE LEAD PATCHES 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 10011426 ↗
• MalfunctionApr 29, 2020High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIGH VOLTAGE EPICARDIAL LEAD PATCHES HAS HIGH IMPEDANCE. THE LEAD PATCHES WILL BE REVISED AT FUTURE DATE THAT HAS NOT BEEN SET. THE LEAD PATCHES 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 10011380 ↗
• InjuryOct 15, 2019Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS ADDITIONALLY NOTED THAT THE RV COIL WAS FRACTURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9191604 ↗
• InjuryMay 7, 2019Signal Artifact/Noise; Fracture; Over-Sensing; Decreased Sensitivity; Impedance Problem; Signal Artifact/Noise; Fracture; Over-Sensing; Decreased Sensitivity; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) COIL OF THE HIGH VOLTAGE LEFT VENTRICULAR (LV) EPICARDIAL LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR AN ELEVATED NUMBER OF SHORT V-V INTERVALS, VARYING RV COIL IMPEDANCE, AND NOISE ON HIGH RATE NON-SUSTAINED EPISODES. IT WAS FURTHER REPORTED THAT THE R-WAVES WERE DIMINISHED AND THE RV COIL WAS FRACTURED. THE LEAD WAS REPROGRAMMED AND LATER 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 8587898 ↗
• InjuryMar 28, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT THE SUPERIOR VENA CAVA (SVC) COIL OF THE PATIENT'S EPICARDIAL LEAD TRIGGERED AN ALERT FOR LOW IMPEDANCE. THE SVC COIL WAS PROGRAMMED OFF AND THE LEAD WILL CONTINUE TO BE MONITORED ON A DAILY BASIS. 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 8460669 ↗
• InjuryMar 20, 2019High impedance; Low impedance; Device Dislodged or Dislocated; High impedance; Low impedance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR IMPEDANCE OUT OF RANGE IN THE DEFIBRILLATOR COILS. IT WAS FOUND THAT THE SUPERIOR VENA CAVA (SVC) EPICARDIAL PATCH HAD LOW IMPEDANCE AND HAD BEEN SEEN TO HAVE HIGH IMPEDANCE. A CHEST X-RAY SHOWS THAT THE EPICARDIAL PATCH HAD MIGRATED. THE EPICARDIAL PATCH WAS CAPPED AND A NEW EPICARDIAL PATCH WAS IMPLANTED. IT WAS FURTHER REPORTED THAT A TRANSVENOUS LEAD WAS ATTEMPTED TO BE IMPLANTED BUT NOT USED. THE TRANSVENOUS LEAD HAD HIGH IMPEDANCE AND FAILED DEFIBRILLATION THRESHOLD (DFT) TESTS. THE LEAD WAS REMOVED AND A SUBCUTANEOUS LEAD WAS ATTEMPTED TO BE IMPLANTED. WHILE ATTEMPTING TO IMPLANT THE SUBCUTANEOUS LEAD, THE PHYSICIAN NICKED THE RIGHT ATRIUM CAUSING BLEEDING. THE PHYSICIAN HAD TO PERFORM OPEN HEART SURGERY TO REPAIR THE WOUND. SINCE THE CHEST CAVITY WAS OPENED, THE PHYSICIAN DECIDED TO IMPLANT AN EPICARDIAL PATCH AFTER THE WOUND WAS TREATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8437758 ↗
• MalfunctionApr 25, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S SPOUSE PHONED INTO PATIENT/TECHNICAL SERVICE DUE TO HEARING AN AUDIBLE ALERT FROM THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). LATER THAT SAME DAY THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT. A REMOTE TRANSMISSION WAS SENT. INFORMATION RECEIVED ON THE REMOTE TRANSMISSION WAS REVIEWED BY QUALIFIED PERSONNEL. IT WAS DETERMINED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) DEFIBRILLATION COIL PATCH AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL PATCH HAD TRIGGERED ALERTS FOR HIGH IMPEDANCE. WHICH COULD BE SUGGESTIVE OF A LEAD FRACTURE. FOLLOW-UP WAS CONDUCTED. IT WAS VERIFIED THAT NO REPROGRAMMING HAS BEEN COMPLETED AT THIS TIME. THE 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 7462853 ↗
• MalfunctionApr 25, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT'S SPOUSE PHONED INTO PATIENT/TECHNICAL SERVICE DUE TO HEARING AN AUDIBLE ALERT FROM THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). LATER THAT SAME DAY THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT. A REMOTE TRANSMISSION WAS SENT. INFORMATION RECEIVED ON THE REMOTE TRANSMISSION WAS REVIEWED BY QUALIFIED PERSONNEL. IT WAS DETERMINED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) DEFIBRILLATION COIL PATCH AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL PATCH HAD TRIGGERED ALERTS FOR HIGH IMPEDANCE. WHICH COULD BE SUGGESTIVE OF A LEAD FRACTURE. FOLLOW-UP WAS CONDUCTED. IT WAS VERIFIED THAT NO REPROGRAMMING HAS BEEN COMPLETED AT THIS TIME. THE 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 7462846 ↗
• InjuryOct 6, 2017High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENTS DEFIBRILLATION EPICARDIAL PATCH LEAD EXHIBITED HIGH IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED WITH A ENDOCARDIAL RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A "MALFUNCTION." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6924089 ↗