NA 6725Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00613994501035), received between Jul 25, 2019 and Apr 13, 2026 — classified as 1 death, 33 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 39 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A SYSTEMIC METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS INFECTION AND WAS REPLACED WITH A LEADLESS PACEMAKER. THE PATIENT EXPERIENCED FEVER AND BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Fever

  MAUDE report 24861100 ↗
• InjuryMar 10, 2026Adverse 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 AND EROSION . NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Medical device site infection

  MAUDE report 24559557 ↗
• MalfunctionFeb 11, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS EXPLANTED DUE TO PERFORATION THAT REQUIRED A STERNOTOMY FOR EXTRACTION AND THE PIN PLUG WAS USED FOR THE RV PORT. AN ERROR WAS MADE INITIALLY INDICATING THE PIN PLUG WAS NOT IMPLANTED AND THE STATUS FOR THE PIN PLUG HAS BEEN UPDATED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316783 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  THE PIN PLUG WAS REPORTED IN ASSOCIATION WITH THE CRT-D SYSTEM. THE PIN PLUG IS NOT CONSIDERED AN ACTIVE PART OF THE DEVICE SYSTEM AND WILL THEREFORE BE PROCESSED AS A NON-COMPLAINT. THERE IS NOT A DIRECT ALLEGATION AGAINST THE PIN PLUG IN THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 23992225 ↗
• MalfunctionDec 23, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PIN PLUG ADAPTOR WAS NOT IMPLANTED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879718 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO AND A HALF MONTHS POST IMPLANT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. ADDITIONALLY, THE PATIENT EXPERIENCED PURULENT DISCHARGE AND REDNESS. THE PATIENT'S LEADLESS PACEMAKER WAS PROGRAMMED BACK ON. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 23789017 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH PAIN, SWELLING, AND DISCOMFORT. 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: Discomfort; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 22546044 ↗
• InjuryJul 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED. THE REASON FOR EXPLANTATION WAS NOT PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22510205 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. ADDITIONALLY, THE PATIENT EXPERIENCED BACTEREMIA AND METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Unspecified Infection

  MAUDE report 22330782 ↗
• InjuryMay 23, 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 AN INFECTION AND THE ORGANISM WAS REPORTED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. ADDITIONALLY, THE PATIENT EXPERIENCED BACTEREMIA. A LEADLESS PACEMAKER WAS IMPLANTED THE SAME DAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 22078519 ↗
• InjuryMay 8, 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. ADDITIONALLY, THE PATIENT EXPERIENCED BACTEREMIA WITH REDNESS AND PURULENT DISCHARGE. A NEW CRT-D SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Erythema; Medical device site infection; Purulent Discharge; Unspecified Infection

  MAUDE report 21988451 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OF UNKNOWN SOURCE AND ORGANISM, ALONG WITH REDNESS, OCCURRED IN A PATIENT WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. THE CRTD SYSTEM WAS REMOVED AND FOUR DAYS LATER A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 21293155 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS AFTER DEVELOPING A BACTERIAL INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A TEMPORARY LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Sepsis

  MAUDE report 21240240 ↗
• InjuryJan 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AND A HALF POST CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT, THE PATIENT EXPERIENCED A BACTERIAL INFECTION AT THE INCISION IN ADDITION TO PURULENT DISCHARGE AND WOUND DEHISCENCE. THE CRT-D SYSTEM WAS SUBSEQUENTLY EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 21186573 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTEREMIA INFECTION WITH FEVER. THE INFECTION WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS, AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Fever

  MAUDE report 21159090 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND A POCKET INFECTION WAS IDENTIFIED. THE CARDIAC RESYNCHRONIZATION THERAPY DE FIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 20017607 ↗
• InjuryJul 12, 2024Adverse 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 AND NOT REPLACED DUE TO THE PATIENT EXPERIENCING AN ALLERGIC REACTION TO NICKEL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypersensitivity/Allergic reaction; Unspecified Infection

  MAUDE report 19733803 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY A MONTH POST IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), THE PATIENT EXPERIENCED AN INFECTION, PURULENT DISCHARGE/PUS, AND BACTEREMIA. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE CRT-P SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Drug Resistant Bacterial Infection

  MAUDE report 19607677 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER DUE TO AN INFECTION. IT WAS NOTED THAT A PIN PLUG ERODED THROUGH THE DEVICE POCKET AT THE INCISION LINE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19605919 ↗
• InjuryJun 25, 2024Adverse 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 AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 19604582 ↗
• InjuryMay 22, 2024Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE SOURCE OF INFECTION WAS PATIENT'S LEFT KNEE. CULTURES TAKEN FROM PACER POCKET, NOTHING WAS FOUND.

  Patient problems: Sepsis

  MAUDE report 19370082 ↗
• InjuryJun 15, 2023Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE ATRIAL PIN PLUG WAS IMPLANTED OVER SIX MONTHS PAST THE USE BEFORE DATE. THE PLUG 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 17136430 ↗
• InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEFT SIDED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE WORLD-WIDE RANDOMIZED ANTIBIOTIC ENVELOPE INFECTION PREVENTION TRIAL. IT WAS FURTHER REPORTED THAT THE LV LEAD WAS RETURNED AFTER BEING EXPLANTED WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM DUE TO A POCKET INFECTION JUST OVER ONE MONTH POST-GENERATOR CHANGE. A TEMPORARY LEADLESS PACEMAKER SYSTEM WAS IMPLANTED UNTIL THE PATIENT RECEIVED A REPLACEMENT SINGLE-CHAMBER SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16198524 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REMOVED DUE TO A POCKET INFECTION. THE SYSTEM WAS NOT REPLACED AT THIS TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15250836 ↗
• InjuryAug 10, 2022Adverse 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 PERSISTENT BACTEREMIA. THE CRT-D DEVICE WAS REPLACED WITH A PACEMAKER AND THE REST OF THE SYSTEM WILL BE REPLACED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 15202150 ↗