NA 6721L-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00681490148733), received between Jun 8, 2017 and Feb 16, 2026 — classified as 12 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Low impedance” (9 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) AND ELEVATED RV THRESHOLD. THE LEFT VENTRICULAR (LV) LEAD HAD EXHIBITED NO CAPTURE. THE LV LEAD WAS CAPPED AND 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 24345059 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEM INFECTION AND EROSION. IT WAS ALSO NOTED THAT THE PATIENT DEVELOPED PAIN AND REDNESS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Pain; Unspecified Infection

  MAUDE report 21371005 ↗
• MalfunctionAug 22, 2024Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL PATCH DISPLAYED A DROP IN RV DEFIBRILLATION IMPEDANCE AND TRIGGERED AN OUT OF RANGE (OOR) ALERT FOR LOW DEFIBRILLATION IMPEDANCE FIVE DAYS POST IMPLANT. 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 20034878 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT, FEVER, AND PAIN. IT WAS DETERMINED THAT THE PATIENT HAD A POCKET INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Fever; Pain; Unspecified Infection

  MAUDE report 19299623 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT, FEVER, AND PAIN. IT WAS DETERMINED THAT THE PATIENT HAD A POCKET INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Fever; Pain; Unspecified Infection

  MAUDE report 19299580 ↗
• 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 18998697 ↗
• InjuryFeb 26, 2024Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THERE WAS OUT OF RANGE AND HIGH AND VARYING IMPEDANCE ON THE EXTRAVASCULAR COIL OF THE EPICARDIAL PATCH. IT WAS FURTHER REPORTED THAT THE EPICARDIAL PATCH WAS FRACTURED. THE LEAD WAS CAPPED, AND A PREVIOUSLY CAPPED HV LEAD WAS REACTIVATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18779323 ↗
• MalfunctionSep 7, 2023Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE DEFIBRILLATION RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR A SPIKE IN 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 17698643 ↗
• MalfunctionAug 15, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THERE WAS AN ALERT ON THE RIGHT VENTRICULAR (RV) LEAD FOR OUT OF RANGE DEFIBRILLATION IMPEDANCE AND THE RV LEAD HAD CHRONICALLY LOW IMPEDANCE. IT WAS FURTHER REPORTED THAT THE SUPERIOR VENA CAVA (SVC) EPICARDIAL PATCH LEAD HAD LOW IMPEDANCE. THE RV LEAD AND SVC EPICARDIAL PATCH 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 17550224 ↗
• MalfunctionJan 24, 2023Low impedance; Impedance Problem; Low impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE SUPERIOR VENA CAVA (SVC) EPICARDIAL PATCH LEAD HAD LOW IMPEDANCE. THE SVC EPICARDIAL PATCH LEAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233992 ↗
• MalfunctionAug 10, 2022Defibrillation/Stimulation Problem; Low impedance; Defibrillation/Stimulation Problem; Low impedance

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE DISPLAYED A SHORT CIRCUIT PROTECTION THAT WAS TRIGGERED DURING HIGH VOLTAGE THERAPY, AND LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. IT WAS NOTED THAT THIS OCCURRED DURING THE IMPLANT PROCEDURE AT DEFIBRILLATION THRESHOLD TESTING AFTER THE DEVICE DELIVERED SEVERAL APPROPRIATE, AND FULL ENERGY SHOCKS, WHICH FAILED. A MANUAL DEFIBRILLATION FROM THE DEVICE WAS DELIVERED AND THE RHYTHM WAS SUCCESSFULLY TERMINATED DESPITE DELIVERING LESS THAN PROGRAMMED ENERGY. IT WAS ALSO REPORTED THAT RIGHT VENTRICULAR (RV) DEFIBRILLATION AND SUPERIOR VENA CAVA (SVC) IMPEDANCE MEASUREMENTS WERE LOW. THE DEVICE AND 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 15201870 ↗
• MalfunctionAug 10, 2022Defibrillation/Stimulation Problem; Low impedance; Defibrillation/Stimulation Problem; Low impedance

  IT WAS REPORTED THAT AN INTERNAL REVIEW OF DATA TRANSMITTED FROM THE DEVICE DISPLAYED A SHORT CIRCUIT PROTECTION THAT WAS TRIGGERED DURING HIGH VOLTAGE THERAPY, AND LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY WAS DELIVERED. IT WAS NOTED THAT THIS OCCURRED DURING THE IMPLANT PROCEDURE AT DEFIBRILLATION THRESHOLD TESTING AFTER THE DEVICE DELIVERED SEVERAL APPROPRIATE, AND FULL ENERGY SHOCKS, WHICH FAILED. A MANUAL DEFIBRILLATION FROM THE DEVICE WAS DELIVERED AND THE RHYTHM WAS SUCCESSFULLY TERMINATED DESPITE DELIVERING LESS THAN PROGRAMMED ENERGY. IT WAS ALSO REPORTED THAT RIGHT VENTRICULAR (RV) DEFIBRILLATION AND SUPERIOR VENA CAVA (SVC) IMPEDANCE MEASUREMENTS WERE LOW. THE DEVICE AND 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 15201090 ↗
• InjuryMay 26, 2022High impedance; Impedance Problem; High Capture Threshold; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL LEAD EXHIBITED FLUCTUATING AND UNDEFINED HIGH DEFIBRILLATION IMPEDANCE. THE RV EPICARDIAL 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 14516237 ↗
• MalfunctionMar 31, 2022Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THEIR WAS AN ALERT ON THE RIGHT VENTRICULAR (RV) LEAD FOR HIGH/UNDEFINED DEFIBRATION IMPEDANCE AND HIGH/UNDEFINED PACING IMPEDANCE. IT WAS ALSO NOTED THAT THEIR WAS NOISE ON THE RV COIL. IT IS SUSPECTED THAT THE ISSUES MAY BE DUE TO A PLURAL EFFUSION WITH CHEST TUBE PLACEMENT. THERE IS NO ALLEGATION THAT THE PLURAL EFFUSION WAS CAUSED DUE TO THE ICD SYSTEM. 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 13966105 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11644915 ↗
• MalfunctionJul 31, 2020Low impedance; Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED ADDITIONAL HIGH THRESHOLDS AND NO CAPTURE AT HIGH OUTPUTS. THE RV PACE/SENSE LEAD EXHIBITED ADDITIONAL HIGH THRESHOLDS AND OVERSENSING. THE PATIENT HAS A SUBCUTANEOUS RV DEFIBRILLATION LEAD AND A SUBCUTANEOUS RV DEFIBRILLATION PATCH, AND PREVIOUS ALERTS FOR LOW DEFIBRILLATION IMPEDANCE WERE NOTED. THE LV LEAD, RV LEAD PACE/SENSE LEAD, RV SUBCUTANEOUS DEFIBRILLATION LEAD AND RV DEFIBRILLATION PATCH 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 10353728 ↗
• InjuryMar 18, 2020Fracture; High impedance; Fracture; High impedance

  THE PATIENT REPORTING HEARING BEEPING AND WONDERED IF IT WAS COMING FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ALERT WAS INDICATED TO HAVE BEEN TRIGGERED DUE TO HIGH IMPEDANCE ON THE EPICARDIAL PATCH RV COIL AND SVC COIL AND IN THE RV TIP TO COIL PACING IMPEDANCE MEASUREMENT. A FRACTURE WAS SUSPECTED. REPROGRAMMED WAS PERFORMED TO TURN THE LEAD OFF. A REPLACEMENT IS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9847577 ↗
• MalfunctionMay 1, 2019High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION EPICARDIAL LEAD AND THE LEFT VENTRICULAR (LV) DEFIBRILLATION EPICARDIAL LEAD EXHIBITED VARYING, AND HIGH UNDEFINED IMPEDANCE MEASUREMENTS. IT WAS FURTHER REPORTED THAT, "THE IMPLANTING PHYSICIAN DID NOT SUTURE THE PATCHES TO THE HEART AND DID AN UNCONVENTIONAL OFF LABEL ATTACHMENT OF THE PATCHES TO THE HEART WITH STAPLES." BOTH 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 8571044 ↗
• MalfunctionApr 4, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT THE SVC COIL AND RV COIL ON THE EPICARDIAL LEADS TRIGGERED ALERTS FOR LOW IMPEDANCE WITHIN A WEEK OF IMPLANT. 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 8485174 ↗
• MalfunctionApr 4, 2019Low impedance; Low impedance

  IT WAS REPORTED THAT THE SVC COIL AND RV COIL ON THE EPICARDIAL LEADS TRIGGERED ALERTS FOR LOW IMPEDANCE WITHIN A WEEK OF IMPLANT. 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 8485148 ↗
• InjuryOct 5, 2018Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY DEPLETED PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE TWO EPICARDIAL DEFIBRILLATION PATCHES DISLODGED AS THEY APPEARED TO HAVE MIGRATED AWAY FROM THE HEART TOWARDS THE DIAPHRAGM. THE PATCHES WERE CAPPED. THE SURGEON WAS UNABLE TO RETRIEVE THE DISLODGED PATCHES AS ONE HAD MIGRATED TO A TROUGH AROUND THE DIAPHRAGM AND ONE HAD SCARRED OVER BELOW AND BEHIND THE HEART. A SUBCUTANEOUS COIL WAS IMPLANTED AND SUCCESSFULLY CONVERTED THE PATIENT DURING DEFIBRILLATION TESTING. THE COIL 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 7940104 ↗
• InjuryJul 19, 2018Fracture; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S HUSBAND THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD FRACTURED AND CAUSED MULTIPLE INAPPROPRIATE SHOCKS. THE PATIENT WENT INTO ATRIAL FIBRILLATION (AF) AND TURNED BLUE AND WAS REVIVED WITH AN AUTOMATED EXTERNAL DEFIBRILLATOR. THE HUSBAND CLAIMED THAT THE LEAD WAS REPROGRAMMED OFF BUT NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Shock from Patient Lead(s)

  MAUDE report 7703993 ↗
• MalfunctionJun 21, 2018High impedance; High impedance

  IT WAS REPORTED THAT THERE WERE LEAD WARNINGS FOR OUT OF RANGE HIGH IMPEDANCE ON BOTH DEFIBRILLATION LEADS. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION. 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 7627390 ↗
• MalfunctionJun 21, 2018High impedance; High impedance

  IT WAS REPORTED THAT THERE WERE LEAD WARNINGS FOR OUT OF RANGE HIGH IMPEDANCE ON BOTH DEFIBRILLATION LEADS. FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION. 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 7627389 ↗
• InjuryMay 18, 2018Signal Artifact/Noise; Fracture; Over-Sensing; Signal Artifact/Noise; Fracture; Over-Sensing

  IT WAS REPORTED THAT THERE WAS A LEAD INTEGRITY ALERT FOR HIGH SENSING INTEGRITY COUNTER (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD AND A NON-SUSTAINED HIGH RATE EPISODE. THE RV 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 7526730 ↗