NA 5867-3M (UDI 00613994500298)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994500298), received between Aug 21, 2018 and Jan 10, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Capturing Problem” (1 report).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST REPLACEMENT OF AN IMPLANTABLE PULSE GENERATOR (IPG), THE PATIENT EXPERIENCED A POCKET INFECTION AND SEPSIS. THE IPG SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 21124244 ↗
• InjuryJul 10, 2024Adverse 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 EXPLANTED DUE TO AN INFECTION AND REPLACED BY A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19711616 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO HOSPITAL WITH POSSIBLE INCISION ISSUES ONE MONTH AFTER THE IMPLANTABLE CARDIOVERTER DE FIBRILLATOR (ICD) SYSTEM WAS IMPLANTED. UPON TESTING AND X-RAY, THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED INTO THE ATRIUM AND THE EPICARDIAL LEAD INCISION WAS ¿OOZING¿. DURING RV LEAD REPOSITION, WHEN THE PHYSICIAN OPENED THE DEVICE POCKET, IT APPEARED TO BE INFECTED. THE PHYSICIAN DECIDED TO REMOVE THE ICD SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13969167 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE ENTIRE PACING SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). ANTIBIOTIC TREATMENT WAS ADMINISTERED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12909924 ↗
• MalfunctionJul 27, 2020Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT DURING USE OF THE RIGHT ATRIAL (RA) LEAD REMOTE TRANSMISSION REVEALED A TREND FOR ATRIAL THRESHOLDS AND IMPEDANCE INCREASE. THE RA LEAD REMAINS IN USE. THE PATIENT WILL BE MONITORED IN CLINIC AND REMOTE TRANSMISSIONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10329294 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S TRANSVENOUS PACING SYSTEM WAS EXPLANTED DUE TO INFECTION AND GROWTH ON THE LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9864413 ↗
• InjuryAug 26, 2019Adverse 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 EXPLANTED DUE TO POCKET EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 8933016 ↗
• InjuryAug 22, 2019Adverse 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) AND LEADS WERE EXPLANTED DUE TO POCKET INFECTION. CULTURES WERE TAKEN. ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8922712 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR SYSTEM DUE A SUSPECTED POCKET INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND A REPLACEMENT SYSTEM WILL BE IMPLANTED UPON RESOLUTION OF THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8485485 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS EXPLANTED DUE TO INFECTION OF UNKNOWN SOURCE. ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7801843 ↗