Maximo® II CRT-D D284TRKRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00613994446916), received between Apr 6, 2017 and Jul 18, 2025 — classified as 19 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM AND IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WERE EXPLANTED AND REPLACED WITH A LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22541755 ↗
• InjuryJun 2, 2023Adverse 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 REMOVED DUE TO INFECTION. A LEADLESS PACEMAKER WAS THEN IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17051372 ↗
• MalfunctionOct 9, 2020Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658939 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WERE SIGNS OF PRE-EROSION AT THE DEVICE SITE. THE DEVICE WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 9855705 ↗
• MalfunctionAug 19, 2019Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS NOT CONNECTING WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). TROUBLESHOOTING WAS OFFERED HOWEVER IT WAS DECLINED. MONITOR WAS VERIFIED AND FOUND OUT THAT THE PATIENT WAS NOT ENROLLED IN THE SYSTEM. THE DEVICE AND MONITOR 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 8906641 ↗
• InjuryJan 30, 2019Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE SHOCKS DUE TO ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). THE PATIENT WAS STARTED ANTIARRHYTHMIC MEDICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 8290730 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND IT WAS OBSERVED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE DEVICE HAD ERODED THROUGH THE POCKET. IT WAS NOTED THE PATIENT HAD BEEN LOST TO FOLLOW-UP AND THEIR DEVICE HAD BEEN AT ERI FOR TWO YEARS AND HAD BEEN ALERTING EVERY MORNING FOR TWO YEARS. THE SURGEON ADDED THE PATIENT WAS EXPERIENCING A CHRONIC POCKET INFECTION THAT THE PATIENT HAD IGNORED. CULTURES WERE TAKEN AND ANTIBIOTICS WERE ADMINISTERED; THE CRT-D SYSTEM WAS EXTRACTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 8215987 ↗
• MalfunctionNov 1, 2018Failure to Charge; Delayed Charge Time; Failure to Charge; Delayed Charge Time

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ALERTED FOR A CHARGE CIRCUIT TIMEOUT WHICH OCCURS WHEN CHARGE TIMES EXCEED A CERTAIN THRESHOLD. IT WAS NOTED THAT THE PATIENT HAD ALREADY RECEIVED A HEART TRANSPLANT AND THE DEVICE WAS NO LONGER PROVIDING ANY THERAPY. THE DEVICE REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8027909 ↗
• InjuryOct 18, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7980615 ↗
• InjuryOct 16, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7971006 ↗
• InjurySep 19, 2018Inappropriate/Inadequate Shock/Stimulation; Protective Measures Problem; Inappropriate/Inadequate Shock/Stimulation; Protective Measures Problem

  IT WAS REPORTED THAT THE PATIENT HEARD A "BOOM" AND BEGAN TO SHAKE IN THEIR CHAIR. IT WAS NOTED A BEEPING SOUNDS WAS ALSO HEARD. FOLLOW UP YIELDED NO INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shaking/Tremors; Shock from Patient Lead(s)

  MAUDE report 7891352 ↗
• InjuryJun 27, 2018Mechanical Problem; Impedance Problem; Mechanical Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED IRREGULAR AND INCONSISTENT IMPEDANCE ON BOTH DEFIBRILLATION COILS AS SEEN THROUGH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), POSSIBLY DUE TO IMPENDING FRACTURE. THE CRT-D WAS EXPLANTED AND REPLACED. MULTIPLE IMPEDANCE MEASUREMENTS WERE TAKEN THROUGH THE NEW DEVICE AND WERE WITHIN NORMAL LIMITS. THE PHYSICIAN REQUESTED CONFIRMATION OF A HEADER ISSUE WITH THE REPLACED DEVICE. IT WAS ALSO REPORTED THAT RISING IMPEDANCE WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. NO ACTION WAS TAKEN AND THE 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 7642454 ↗
• InjuryApr 27, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7470359 ↗
• InjuryApr 25, 2018Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE HAD REACHED BATTERY DEPLETION PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7459593 ↗
• InjuryApr 10, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE DEVICE CHARGE CIRCUIT WAS INACTIVE AND AN ALERT TRIGGERED. THE PATIENT HAD BEEN LOST TO FOLLOW-UP AND THE DEVICE WAS AT END OF SERVICE (EOS). THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7417686 ↗
• InjuryFeb 8, 2018Failure to Interrogate; Pacing Problem; Battery Problem; Failure to Interrogate; Pacing Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT HAD BEEN LOST TO FOLLOW UP AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED END OF SERVICE (EOS). THE CRT-D WAS UNABLE TO BE INTERROGATED AND THE PATIENT'S HEART RATE WAS IN THE RANGE OF 40 BEATS PER MINUTE. THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 7258088 ↗
• MalfunctionFeb 8, 2018Pacing Problem; Invalid Sensing; Pacing Problem; Invalid Sensing

  IT WAS REPORTED THAT THE PATIENT POSSIBLY RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). FOLLOW UP YIELDED NO INFORMATION. THE DEVICE 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 7254006 ↗
• InjuryOct 6, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT STATED THAT THEIR DEVICE "FAILED". THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6925582 ↗
• InjuryAug 9, 2017Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing; Inappropriate/Inadequate Shock/Stimulation; Invalid Sensing

  IT WAS REPORTED THAT THERE WAS OCCASIONAL RIGHT ATRIAL (RA) LEAD P-WAVE UNDER-SENSING DURING AN ARRHYTHMIA. IN ADDITION, POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) WAS NOTED AND THE AF WAS TREATED WITH A FAST VENTRICULAR TACHYCARDIA (VT) SHOCK FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE RA LEAD AND CRT-D 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 6781019 ↗
• InjuryAug 9, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE REACHED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780463 ↗
• InjuryJun 8, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN ANTICIPATED. IT WAS NOTED THE PATIENT'S COMPETITORS RIGHT ATRIAL (RA) LEAD WAS PROGRAMMED AT A HIGH OUTPUT WHICH MAY HAVE CONTRIBUTED TO THE PREMATURE BATTERY DEPLETION OF THE DEVICE. IT WAS ALSO NOTED THE PATIENT IS CURRENTLY ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY. THE DEVICE WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6624848 ↗
• InjuryApr 6, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6469804 ↗
• InjuryApr 6, 2017Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6469143 ↗