NA 6984MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00681490153621), received between May 24, 2018 and Mar 4, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE RIGHT ATRIAL (RA) LEAD, THE RIGHT VENTRICULAR (RV) LEAD AND THE ADAPTER WERE REMOVED. THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE EPI-ANT RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13665698 ↗
• MalfunctionJun 11, 2020Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10142732 ↗
• InjuryJun 20, 2019Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture

  IT WAS REPORTED THAT THE LEAD EXTENDER WAS FRACTURED/ LOOSE RESULTING IN THE RIGHT ATRIAL (RA) LEAD NOT FUNCTIONING CORRECTLY. THE LEAD WAS CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8715582 ↗
• InjuryMay 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EROSION OCCURRED. IT WAS UNKNOWN IF THE EROSION WAS DUE TO THE LEAD OR THE LEAD EXTENDER. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED WITH A PACING SYSTEM AS THE PATIENT NO LONGER MET CRITERIA FOR A TACHY DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 8578693 ↗
• InjuryJun 4, 2018Adverse 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 EXTRACTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7566689 ↗
• InjuryJun 4, 2018Adverse 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 EXTRACTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7566666 ↗
• InjuryJun 4, 2018Adverse 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 EXTRACTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 7566584 ↗
• InjuryMay 24, 2018Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD ALERTED FOR AN OUT OF RANGE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE. THE PATIENT HAD COMPLAINED OF CHEST HEAVINESS AND SHORTNESS OF BREATH UPON EXERTION. IT WAS ADDITIONALLY REPORTED THE LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED. THE RIGHT ATRIAL (RA) LEAD AND RV LEAD WERE REPROGRAMMED. THE LEADS REMAIN IN USE. THE PATIENT IS A PARTICIPANT IN THE WORLD-WIDE RANDOMIZED ANTIBIOTIC ENVELOPE INFECTION PREVENTION TRIAL CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 7542216 ↗