INOGEN™ X4 CRT-D G146Recalls & reported problems

Summary

The FDA's MAUDE database contains 201 adverse event reports that list this exact device (DI 00802526534577), received between Apr 22, 2016 and Sep 14, 2026 — classified as 6 deaths, 132 injuries, 63 malfunctions.

The most frequently reported specific device problem is “High impedance” (52 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 201 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  It was reported that electrogram (EGM) review was requested for this cardiac resynchronization therapy defibrillator (CRT-D) due to observed pauses less than two seconds. Upon review, each pause was preceded by an atrial fibrillation (AF) beat. When atrial flutter response (AFR) is triggered, post-ventricular atrial refractory period (PVARP) is extended and the ventricular pace (Vp) cannot track the p-wave. This appears related to farfield oversensing marked as premature atrial contraction (PAC), just prior. Technical Services (TS) discussed troubleshooting options and programming considerations, recommending extending the blanking from Smart to Fixed and turning off AFR. Additional information received reported that the recommended programming changes were completed. This CRT-D remains in service, and will continue to be monitored. No additional adverse patient effects were reported.

  Patient problems: Bradycardia

  MAUDE report 50748339 ↗
• MalfunctionFeb 18, 2026Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED FAR-FIELD OVERSENSING LED TO INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR). PROGRAMMING OPTIONS WERE PERFORMED. CURRENTLY, THIS PRODUCT REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379741 ↗
• InjuryJan 21, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT ABLE TO BE INTERROGATED WITH A CONSULT UNIT. SUBSEQUENTLY THIS DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24140801 ↗
• InjuryAug 6, 2025Premature Discharge of Battery; High impedance; Battery Problem; Premature Discharge of Battery; High impedance; Battery Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THIS DEVICE HAD 2 YEARS OF BATTERY LIFE REMAINING. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED REPLACEMENT. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD RECORDED HIGH OUT OF RANGE PACING IMPEDANCES ON THE LEFT VENTRICULAR (LV) CHANNEL PRIOR TO EXPLANATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731909 ↗
• MalfunctionJul 8, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED REVIEW OF THE PRESENTING ELECTROGRAM STORED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. TECHNICAL SERVICES (TS) REVIEWED PER REQUEST. TS ADVISED THERE IS INTERMITTENT LOSS OF CAPTURE ON THE LEFT VENTRICULAR CHANNEL. THE HCP PROVIDED THE PATIENT WOULD BE SEEN IN THE CLINIC FOR AN EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT PROVIDED AT THIS TIME. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Device Overstimulation of Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440540 ↗
• MalfunctionMay 12, 2025Over-Sensing; Data Problem; Over-Sensing; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING ON ITS RIGHT ATRIAL (RA) CHANNEL CAUSED BY THE PATIENTS CARDIAC CONTRACTILITY MODULATION DEVICE. THIS RESULTED IN THE CRT-D TO SWITCH MODES AND POSSIBLY MISS TRACKING SOME P-WAVES OF THE PATIENTS RHYTHM. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA AS WELL AS PROGRAMMING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004682 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTIC. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21995994 ↗
• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21854060 ↗
• InjuryApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21853580 ↗
• MalfunctionApr 16, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21852619 ↗
• MalfunctionJan 2, 2025Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THAT THE FIELD PRESENTATIVE HAD DIFFICULTY INTERROGATION THIS PATIENT WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). ADDITIONALLY, THE PATIENT HAS A LEFT VENTRICULAR ASSIST DEVICE (LVAD). AFTER SEVERAL ATTEMPTS OF TROUBLESHOOTING THE REPRESENTATIVE WAS ABLE TO SUCCESSFULLY INTERROGATE THE DEVICE AFTER THE PATIENT RAISED HER ARM ABOVE HER HEAD. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE AT END OF LIFE (EOL). AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) HAD DIFFICULTY INTERROGATING THE DEVICE. A MAGNET WAS USED, AND THEY HEARD A CONSTANT TONE WHICH INDICATES THAT TACHY THERAPY IS PROGRAMMED OFF WHICH IS TYPICAL FOR LVAD PATIENTS AT THIS FACILITY. TECHNICAL SERVICES SUSPECTS ELECTROMAGNETIC INTERFERENCE (EMI) FROM THE LVAD AND PROVIDED TROUBLESHOOTING OPTIONS. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058540 ↗
• MalfunctionOct 3, 2024Signal Artifact/Noise; Over-Sensing; Under-Sensing; Signal Artifact/Noise; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING OF NOISE ON BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEADS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THE NOISE MAY BE FROM A MEDICAL PROCEDURE AND/OR ELECTROMAGNETIC INTERFERENCE (EMI). ADDITIONALLY, UNDERSENSING WAS ALSO OBSERVED. FURTHER REVIEW WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360035 ↗
• InjuryJul 10, 2024High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRTD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 135 OHMS. IT WAS ALSO NOTED THAT THE CRTD IS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND A CHANGEOUT WAS PLANNED. ADDITIONALLY, NO NOISE COULD BE SEEN, AND RIGHT VENTRICULAR PACE IMPEDANCE WAS WITHIN NORMAL LIMITS. TECHNICAL SERVICES (TS) RECOMMENDED A MAX ENERGY R WAVE SYNCH SHOCK AND IF A CODE 1005 INDICATIVE OF AN OPEN CIRCUIT CONDITION DURING SHOCK DELIVERY IS RECORDED THEN LEAD REPLACEMENT WAS RECOMMENDED, HOWEVER IF AFTER THE SHOCK THE SHOCKING IMPEDANCES ARE WITHIN RANGE THE PHYSICIAN CAN CONSIDER MONITORING THE LEAD. THIS CRTD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THIS CRTD WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED TO ASSESS SHOCK LEAD IMPEDANCES. THIS DEVICE WAS SUCCESSFULLY REPLACED AND THE RIGHT VENTRICULAR LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT WAS RETURNED AND IS PENDING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710580 ↗
• MalfunctionJul 3, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING OF NOISY SIGNALS IN ITS RIGHT ATRIAL (RA) AND SHOCK CHANNELS. ALL OTHER LEAD MEASUREMENTS WITHIN RANGE. TECHNICAL SERVICES (TS) WAS CONSULTED AND ADVISED FURTHER REVIEW. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19666221 ↗
• InjuryJun 12, 2024Inappropriate/Inadequate Shock/Stimulation; Data Problem; Inappropriate/Inadequate Shock/Stimulation; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS BEING INTERROGATED BY A PROGRAMMER AND PROGRAMMING WAS BEING PERFORMED DURING AN ATRIAL FIBRILLATION (AF) EPISODE THIS PATIENT EXPERIENCED. AN INAPPROPRIATE COMMANDED ELECTRIC SHOCK WAS DELIVERED WHICH TERMINATED THE RHYTHM. THE DEVICE LISTED THE EPISODE AS A NO THERAPY EVENT EVEN THOUGH THE SHOCK WAS DELIVERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19525129 ↗
• InjuryMay 8, 2024Unexpected Therapeutic Results; Data Problem; Unexpected Therapeutic Results; Data Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOWED THE CLOCK OFF ONE HOUR WHICH WAS RELATED TO DAYLIGHT SAVINGS TIME, SO THE DEVICE WAS WORKING AS EXPECTED. FURTHERMORE, THE DEVICE HAD A SYNCOPAL EPISODE WITH NO REPORT OF SHOCK AND OTHER VENTRICULAR ARRHYTHMIA EPISODE WHICH HAD ANTI-TACHYCARDIA PACING (ATP) AND AN ELECTRIC SHOCK. THE ELECTROGRAM SHOWED DEVICE OPERATING AS PROGRAMMED AND RECENT LEAD TESTS ARE WITHIN NORMAL LIMITS. THE CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 19265921 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO UNKNOWN ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210628 ↗
• MalfunctionNov 17, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM HAD A STORED ATRIAL TACHY RESPONSE (ATR) EPISODE IN WHICH THERE WAS NOISE THAT WAS BEING OVERSENSED ON THE RIGHT ATRIAL (RA) CHANNEL. HOWEVER, THERE WAS NO INAPPROPRIATE THERAPY AS A RESULT. AT THIS TIME, THE DEVICE AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162633 ↗
• MalfunctionNov 15, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REPORTED THAT THE DEVICE MAY HAVE SHORTED AND CAUSED AN EVENT. FURTHER INFORMATION WAS NOT AVAILABLE AT THE TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144619 ↗
• MalfunctionNov 6, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS DEVICE EXHIBITED ATRIAL CHANNEL OVERSENSING OF VENTRICULAR SIGNALS, RESULTING IN INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EVENTS. TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIONS WITH THE HEALTH CARE PROFESSIONAL (HCP). THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072882 ↗
• InjuryOct 23, 2023Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS DEVICE EXHIBITED HIGH IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED, WHILE THE RV LEAD WAS SURGICALLY ABANDONED. BOTH PRODUCTS WERE SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17991878 ↗
• MalfunctionAug 28, 2023Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Under-Sensing; Signal Artifact/Noise; Failure to Capture; Over-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISY SIGNALS DURING AN ATRIAL TACHY RESPONSE (ATR) EPISODE ON THE RIGHT VENTRICULAR (RV) CHANNEL. ADDITIONALLY, ON THE MOST RECENT ATR EPISODES NOISE WAS OBSERVED ON THE SHOCK CHANNEL, TECHNICAL SERVICES (TS) MENTIONED IT WAS LIKELY DUE TO MYOPOTENTIAL. IT WAS ALSO NOTED UNDERSENSING ON THE RV CHANNEL, LEADING INTO OVERPACING AND LOSS OF CAPTURE DUE TO THE HEART WAS NOT READY TO CONTRACT AGAIN. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT, THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED TRUE ATRIAL FIBRILLATION (AF) WITH UNDERSENSING OF RIGHT ATRIAL (RA) SIGNALS. UNDERSENSING AND OVERPACING WERE NOTED THROUGHOUT STRIPS. THE RA SENSITIVITY WAS PROGRAMMED TO 0.25MV AND THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TO REPROGRAM THE DEVICE TO 0.15MV AND CONSIDER VVI(R) IF CHRONIC. THE TRUE BURDEN WAS NOT REALIZED DUE TO UNDERSENSING. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17634240 ↗
• DeathAug 3, 2023Failure to Charge; Failure to Convert Rhythm; Failure to Read Input Signal; Under-Sensing; Low impedance; Defective Device; Failure to Charge; Failure to Convert Rhythm; Failure to Read Input Signal; Under-Sensing; Low impedance; Defective Device

  IT WAS REPORTED THAT THIS PATIENT PASSED AWAY. THE PATIENTS OBITUARY INDICATES THE PATIENT PASSED AWAY AT HOME. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED DATA FROM THE PATIENTS IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE. THERE WAS A STORED EPISODE WHERE THE DEVICE PROVIDED THREE ROUNDS OF ANTI-TACHYCARDIA PACING (ATP) THERAPY FOLLOWED BY A 41 JOULE DEVICE SHOCK FOR A VENTRICULAR ARRHYTHMIA. THE DEVICE SHOCK EXHIBITED AN ASSOCIATED SHOCK FAULT DUE TO A LOW OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD SHOCK IMPEDANCE VALUE. THE SHOCK IMPEDANCE VALUE WAS REPORTED AS LESS THAN 20 OHMS, WHICH MEANS THE MEASURED SHOCK IMPEDANCE WAS LESS THAN THE MINIMUM VALUE, TOO LOW FOR A NUMERICAL RESULT. THE DEVICE SUBSEQUENTLY ATTEMPTED 26 TIMES TO CHARGE FOR AN ADDITIONAL SHOCK, BUT ALL ATTEMPTS FAILED, EXHIBITING SHOCK FAULTS AND ABORTED SHOCK ATTEMPTS DUE TO HIGH VOLTAGE AND THE EPISODE ENDED. THERE WERE 10 SUBSEQUENT NON-SUSTAINED VENTRICULAR EPISODES WHERE NO DEVICE THERAPY WAS PROVIDED. TS NOTED THAT THESE STORED EPISODES SHOWED AN AGONAL RHYTHM AND FUNCTIONAL UNDERSENSING OF THE DEGRADING ELECTRICAL SIGNAL. BOSTON SCIENTIFIC ENGINEERING ALSO REVIEWED THE STO

  Patient problems: Insufficient Information

  MAUDE report 17455009 ↗
• MalfunctionAug 1, 2023Signal Artifact/Noise; Over-Sensing; Pacing Problem; Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED A FALSE PACEMAKER MEDIATED TACHYCARDIA (PMT). FURTHER, PRESENTING ELECTROGRAM (EGM) SHOWED DEVICE OPERATING AS PROGRAMMED. A COUPLE OF YEARS LATER, THE DEVICE RECORDED PMT EPISODES THAT APPEAR TO BE ATRIAL DRIVEN AND DON'T CHANGE WITH PMT ALGORITHM AGAIN, AS WELL AS FALSE ATRIAL TACHY RESPONSE (ATR) EVENTS DUE TO FAR FIELD R WAVE OVER SENSING ON THE ATRIAL ELECTROGRAM. THE CRT-D REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED MENTIONING THAT NOISE OVER SENSING WAS OBSERVED FROM A TEMPORARY PACING DURING A PROCEDURE AND PMT WAS ALSO OBSERVED. NO OUT-OF-RANGE MEASUREMENTS OBSERVED. THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17433914 ↗
• InjuryJul 31, 2023Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IS NOT APPROVED FOR MAGNETIC RESONANCE IMAGING (MRI). THE HEALTH CARE PROFESSIONAL (HCP) NOTED THEY HAVE PREVIOUSLY PERFORMED MRIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED RELATED TO THE OFF-LABEL USE. THIS CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17431491 ↗

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-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-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-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-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-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-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-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-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-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-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-0825-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100

…and 4 more.