RESONATE™ X4 CRT-D G447Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,218 adverse event reports that list this exact device (DI 00802526589539), received between May 2, 2018 and Sep 30, 2026 — classified as 13 deaths, 715 injuries, 490 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (237 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,218 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50951522 ↗
• MalfunctionSep 30, 2026Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing

  It was reported that this right atrial (RA) lead with the cardiac resynchronization therapy defibrillator (CRT-D) exhibited high out of range pacing impedances. There was loss of capture (LOC) noted and noisy signals. Technical Services (TS) reviewed and found this to be indicative of a lead fracture. Programming options were provided. This RA lead and CRT-D remain in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947386 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There were no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50895818 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of the system revision due to infection. No adverse patient effects were reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50865671 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the cardiac resynchronization therapy defibrillator (CRT-D) and right ventricular (RV) lead were explanted and replaced due to other, or non-product performance related reasons. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50813592 ↗
• MalfunctionSep 17, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Device Sensing Problem

  It was reported that the medical doctor (MD) called Technical Services (TS) questioning the right ventricular (RV) sensing and pacing for this cardiac resynchronization therapy defibrillator (CRT-D). TS reviewed the data and noted the presenting electrogram (EGM) showed RV pace followed by atrial sensing and that sometimes there was likely fusion for two beats. TS also noted there was a pacemaker mediated tachycardia (PMT) episode in late August and noise on the RV rate sense channel that was not sensed. TS also discussed there was one beat of right atrial (RA) oversensing and an episode with a premature ventricular contraction (PVC). TS stated there were no anomalies with the RV sensing that they noticed. Information from the field was received and noted the patient would continue to be monitored. No adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808332 ↗
• InjurySep 15, 2026Defibrillation/Stimulation Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered anti-tachycardia pacing (ATP) for ventricular tachycardia; however, the ATP accelerated the rhythm from ventricular tachycardia to ventricular fibrillation. Additionally, the patient experienced syncope during the event. Technical Services (TS) was consulted and confirmed the device was operating as programmed, and a max voltage shock converted the accelerated arrythmia. TS noted that the patient did not feel the shock due to syncope. No additional adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: Syncope/Fainting; Ventricular Fibrillation

  MAUDE report 50774639 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There was no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50774314 ↗
• InjurySep 14, 2026Signal Artifact/Noise

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited noise on the shock and right atrial channels that was not oversensed. Technical Services (TS) recommended continuous monitoring. Subsequently, this CRT-D was explanted and replaced with a new device. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755823 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of the system revision due to infection. No adverse patient effects were reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50725328 ↗
• MalfunctionSep 8, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674032 ↗
• MalfunctionSep 4, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613294 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50611353 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of the system revision due to infection. No adverse patient effects were reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50605550 ↗
• MalfunctionSep 4, 2026High impedance

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) exhibited high out of range shock impedance measurements. Technical Services (TS) was consulted and noted that the measurements had previously been stable and a spike occurred. TS recommended in clinic testing and a vector breakdown to see if the measurement could be reproduced. TS further recommended a defibrillation threshold test if a vector change occurs. No adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602176 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a cardiac resynchronization therapy defibrillator (CRT-D) received a shock therapy. A few days later, the patient was hospitalized due to persistent lightheadedness, dizziness, and headache. A Boston Scientific Technical Services (TS) consultant advised contacting the treating clinician for further evaluation of the reported symptoms. At the time of this report, the CRT-D remained in service. No adverse patient outcomes have been reported.

  Patient problems: Dizziness; Headache

  MAUDE report 50602095 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50599858 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced a low heart rate of 48 beats per minute and low blood pressure readings. Subsequently, a Nurse rechecked and recent blood pressure was 104 over 55 millimeters of mercury and heart rate was 60 to 66 beats per minute. The Boston Scientific Technical Services consultant referred the patient to the device-following physician. As of this time, this CRT-D remains in service. No adverse patient effects were reported.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 50548042 ↗
• InjuryAug 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of the system revision due to infection. No adverse patient effects were reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50388817 ↗
• MalfunctionAug 19, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50329782 ↗
• InjuryAug 19, 2026Failure to Read Input Signal

  It was reported that the pacing from this cardiac resynchronization therapy defibrillator (CRT-D) did not archive the desired reduction below 200ms in the QRS width. The patient underwent a surgical intervention to explant and replace this device with a new CRT-D. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326173 ↗
• InjuryAug 18, 2026Failure to Capture; Defibrillation/Stimulation Problem; Unexpected Therapeutic Results; Under-Sensing; High Capture Threshold

  It was reported that this patient with the cardiac resynchronization therapy defibrillator (CRT-D) was admitted after experiencing a ventricular tachycardia (VT)/ventricular fibrillation (VF) storm. The VF did break after the shocks, but therapy was exhausted and the arrhythmia remained. Technical Services (TS) reviewed and found the device had a delay in delivering therapy due to undersensing. There was also some loss of capture (LOC) noted but the patient appeared to be conducting on their own. Thresholds were noted to be high on the right ventricular (RV) lead. The patient was also noted to be on multiple life support medications. This CRT-D remains in service. No additional adverse patient effects were reported.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50310185 ↗
• InjuryAug 17, 2026Pacing Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) delivered several rounds of inappropriate anti-tachycardia pacing (ATP) due to supraventricular tachycardia (SVT). Device remains in service. Troubleshooting options were discussed. No additional adverse patient effects were reported.Additional information was received and it was reported that this CRT-D was explanted. Additional information was requested but unable to be obtained at this time. No additional adverse patient effects were reported. This CRT-D was returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278462 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There was no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50263479 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) was part of a system revision due to infection. There were no additional adverse patient effects reported. The CRT-D was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50263447 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · Jul 7, 2022 · Open, Classified
  The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-0079-2018 · Oct 4, 2017 · Terminated
  VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharma
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0827-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55

…and 4 more.