Maximo® II DR D284DRGRecalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00613994446602), received between Feb 9, 2017 and Oct 28, 2024 — classified as 1 death, 63 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (17 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 91 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT NOTIFY THE PATIENT WITH AN ALERT WHEN THE BATTERY WAS LOW. THE DEVICE WAS LATER EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551148 ↗
• InjuryOct 22, 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) WAS EXPLANTED DUE TO A BLOOD INFECTION. THE ORGANISM WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 20511139 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 17541582 ↗
• InjuryAug 4, 2023Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Battery Problem; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND LATER END OF SERVICE (EOS). THE DEVICE TRIGGERED AN ALERT FOR CHARGE CIRCUIT TIMEOUT AND AN INACTIVE CHARGE CIRCUIT. THE DEVICE WAS EXPLANTED AND REPLACED. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD DISPLAYED FAR FIELD R-WAVE (FFRW) OVERSENSING. 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 17464319 ↗
• MalfunctionJul 31, 2023Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time; Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED END OF SERVICE (EOS) AND CHARGE CIRCUIT INACTIVE HAS O CCURRED. IN ADDITION, ALERTS WERE TRIGGERED FOR CHARGE CIRCUIT TIMEOUT AND FOR CHARGE TIME GREATER THAN 30 SECONDS. THE ICD 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 17423457 ↗
• InjuryApr 4, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT REVIEW OF A REMOTE TRANSMISSION INDICATED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DELIVERED A NTI-TACHYCARDIA PACING AND SHOCKS FOR AN EPISODE OF VENTRICULAR FIBRILLATION (VF). IT WAS NOTED THAT THE EVENT APPEARED TO START AS AN ATRIAL EVENT AND CONTINUED IN A ONE-TO-ONE PATTERN WITH NO APPARENT CHANGE IN MORPHOLOGY. IT WAS SUSPECTED THAT THE THERAPIES WERE INAPPROPRIATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 13996228 ↗
• MalfunctionNov 9, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR CHARGE CIRCUIT TIMEOUT. THE DEVICE IS AT END OF SERVICE (EOS). THE DEVICE 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 12781498 ↗
• InjuryNov 1, 2021Battery Problem; Reset Problem; Battery Problem; Reset Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727947 ↗
• InjuryOct 19, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT A CHARGE CIRCUIT TIMEOUT/CHARGE CIRCUIT INACTIVE OCCURRED AFTER THE DEVICE REACHED END OF SERVICE (EOS). THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657638 ↗
• MalfunctionSep 22, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT AN ALERT WAS TRIGGERED FOR THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DUE TO CHARGE CIRCUIT TIMEOUT. THE ICD 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 12514407 ↗
• InjuryMay 28, 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 EXPLANTED DUE TO EROSION WITH A POSSIBLE INFECTION. A NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 11900918 ↗
• InjuryMay 25, 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 AN INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11878087 ↗
• MalfunctionApr 20, 2021Failure to Charge; Electrical /Electronic Property Problem; Failure to Charge; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ALERTED FOR CHARGE CIRCUIT TIMEOUT AND CHARGE CIRCUIT INACTIVE. THE ALERTS WERE PROGRAMMED OFF. IT WAS NOTED THAT THE PATIENT AND THE PHYSICIAN CHOSE NOT TO HAVE THE ICD REPLACED WHEN IT REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND ALL DETECTIONS AND THERAPIES WERE PROGRAMMED OFF AT THAT TIME. THE ICD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694235 ↗
• InjuryApr 12, 2021Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED END OF SERVICE (EOS), AND TRIGGERED A CHARGE CIRCUIT TIMEOUT. THE DEVICE WAS PROGRAMMED OFF, AND CURRENTLY REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11649150 ↗
• InjuryApr 1, 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) WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11603065 ↗
• InjuryMar 30, 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 11588774 ↗
• InjuryJan 27, 2021Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS TONING DUE TO A CHARGE CIRCUIT TIMEOUT. IT WAS NOTED THAT APPROXIMATELY TWO MONTHS AGO THE CHARGE CIRCUIT TIMEOUT OCCURRED, AND ALL THE ALERTS HAD PREVIOUSLY BEEN TURNED OFF ON THE DEVICE AS THEY ELECTED NOT TO CHANGEOUT THE DEVICE. SINCE THE DEVICE IS AT END OF SERVICE (EOS) THE PHYSICIAN DECIDED TO TURN OFF TACHYCARDIA THERAPY. THE ICD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11237726 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD AN INFECTION. THE PATIENT ALSO INDICATED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REMOVED FROM THEIR LEFT SIDE, AND A NEW DEVICE IMPLANTED ON THEIR RIGHT SIDE. A FOLLOW-UP INVESTIGATION WITH THE CLINIC CONFIRMED THAT THE PATIENT HAD AN INFECTION IN 2016, AND ONLY THE ICD HAD BEEN EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11163944 ↗
• InjuryJun 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 10179325 ↗
• MalfunctionApr 2, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PAST END OF SERVICE (EOS) AND TRIGGERED A CHARGE CIRCUIT INACTIVE ALERT. THE ICD 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 9915853 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9814049 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 9660393 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION AND EROSION OCCURRED. EROSION REPORTEDLY DUE TO LEAD MOVING ABOVE CAN. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND DEVICE WAS USED AS A TEMPORARY SYSTEM UNTIL INFECTION CLEARED AND SYSTEM WAS THEN REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 9653840 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS IMPLANTED ON THE LEFT SIDE ORIGINALLY, HOWEVER WAS REMOVED APPROXIMATELY TWO MONTHS LATER DUE TO INFECTION. A NEW SYSTEM WAS IMPLANTED ON THE RIGHT SIDE ABOUT SIX WEEKS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9368556 ↗
• MalfunctionNov 22, 2019Delayed Charge Time; Battery Problem; Protective Measures Problem; Delayed Charge Time; Battery Problem; Protective Measures Problem

  IT WAS FURTHER REPORTED THAT THE ALERT TONE WAS NOT A FULL TONE BUT A BROKEN TONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365220 ↗