DYNAGEN™ X4 CRT-D G156Recalls & reported problems

Summary

The FDA's MAUDE database contains 379 adverse event reports that list this exact device (DI 00802526534669), received between Apr 22, 2016 and Sep 30, 2026 — classified as 7 deaths, 212 injuries, 160 malfunctions.

The most frequently reported specific device problem is “High impedance” (119 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 379 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 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 confirmed out of range measurements. TS noted that the system was reprogramming to a different vector with measurements that were within range. No adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945279 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; High impedance; Data Problem

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) system was interrogated with a programmer that had an inaccurate date and time group. TS discussed the programmer would need to be evaluated to resolve this. It was also noted this CRT-D system exhibited high out of range pacing impedance measurements on the right atrial (RA) lead. Technical Services (TS) noted the Atrial Tachy Response (ATR) episode showed non-physiologic noise and discussed it was probable early signs of a lead fracture. It was also noted the patient reported not feeling well recently. The patient was scheduled for an in-clinic interrogation to synch the programmer with the accurate date and time. No additional adverse patient effects were reported. This CRT-D remains in service.

  Patient problems: Discomfort

  MAUDE report 50715895 ↗
• MalfunctionJun 19, 2026Failure to Capture; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THIS SYSTEM WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND A NON BSC RIGHT ATRIAL (RA) LEAD SHOWED UNSTABLE, ELEVATED PACING IMPEDANCES, REACHING OUT OF RANGE VALUES. A SPRING CONTACT BEHAVIOR WAS SUGGESTED. AT A LEAD MEASUREMENT ANALYSIS, LOSS OF CAPTURE (LOC) WAS OBSERVED WITH HIGH, OUT OF RANGE PACING IMPEDANCES AND HIGH PACING THRESHOLDS, BUT AT A SECOND IMMEDIATE ANALYSIS, THERE WAS APPROPRIATE CAPTURE WITH NORMAL THRESHOLDS AND WITHIN RANGE PACING IMPEDANCES. ALSO, FAR FIELD OVER SENSING WAS NOTED THAT WAS NOT RELATED TO NOISY SIGNALS. AS THE CRT-D HAD LESS THAN A YEAR OF REMAINING BATTERY, IT WAS RECOMMENDED TO REPLACE THE CRT-D AND RA LEAD AT THE SAME TIME WHEN BATTERY NEEDED REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25559012 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED DUE TO EROSION. A NEW DEVICE IS EXPECTED TO BE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D IS NO LONGER IN SERVICE.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 25244011 ↗
• MalfunctionApr 29, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED SUDDEN HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ABOVE 3000 OHMS IN THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND FURTHER IN OFFICE AND X-RAY EVALUATION WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25029600 ↗
• InjuryApr 18, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED FARFIELD OVERSENSING OF RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) PACED BEATS ON THE RIGHT ATRIAL (RA) CHANNEL. IN ADDITION, THE PATIENT'S UNDERLYING RIGHT BUNDLE BRANCH BLOCK (RBBB) WAS RESULTING IN EARLY LV SENSE, BIV PACE, AND LV INHIBITION. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY THREE YEARS LATER REPORTED THAT THIS CRT-D UNDERWENT DEVICE REPAIR. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919619 ↗
• InjuryApr 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT BOSTON SCIENTIFIC RECEIVED A THREAT OF LITIGATION RELATED TO THIS DEVICE. THE DEVICE WAS REPAIR AND EXPLANTED WITH NO DEVICE ISSUES REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24908836 ↗
• MalfunctionMar 18, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED PACING IMPEDANCE MEASUREMENT HIGH OUT OF RANGE ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD WAS NOT A BOSTON SCIENTIFIC PRODUCT. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED TROUBLESHOOTING OPTIONS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634074 ↗
• MalfunctionMar 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY AND A SHOCK FOR A POSSIBLE RAPID VENTRICULAR RESPONSE (RVR) RHYTHM DUE TO AN ATRIAL ARRHYTHMIA. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON DATA REVIEW IDENTIFIED HIGH OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS OVER 137 OHMS; AS WELL AS PACEMAKER MEDIATED TACHYCARDIA (PMT) EPISODES. THIS CRTD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24509940 ↗
• MalfunctionFeb 5, 2026Over-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) SYSTEM. UPON REVIEW, TECHNICAL SERVICES (TS) NOTED A LOT OF BIVENTRICULAR (BIV) PACING, LEFT VENTRICULAR (LV) INHIBITION, AND A SMALL RIGHT VENTRICULAR (RV) EGM. THESE OBSERVATIONS WERE LIKELY ATTRIBUTED TO ANALOG BLANKING AND/OR FUSION BEATS. TWO MORPHOLOGIES WERE NOTED: 1 BUNDLE BRANCH BLOCK (BBB) TYPE WITH A SMALLER RV RATE/SENSE EGM, AND ANOTHER MORE NARROW AND LARGER RATE/SENSE EGM. ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED, BUT IT WAS UNCLEAR WHETHER THIS WAS VENTRICULAR TACHYCARDIA (VT) OR SUPRAVENTRICULAR TACHYCARDIA (SVT). WITH RESPECT TO THE LV PACING INHIBITION, IT WAS UNCLEAR WHETHER THIS WAS RELATED TO THE BBB OR LV OVERSENSING. TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO THE PHYSICIAN FOR FURTHER EVALUATION AND POSSIBLE PROGRAMMING OPTIMIZATION. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24265934 ↗
• InjuryJan 30, 2026Over-Sensing; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THE FIELD REPRESENTATIVE CALLED FOR A REVIEW OF A STORED ATRIAL TACHY RESPONSE (ATR) EPISODE FOR THIS PATIENT WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. TECHNICAL SERVICES REVIEWED THE EPISODE, AND IT APPEARS THE PATIENT HAD VENTRICULAR TACHYCARDIA (VT) WITH FARFIELD OVERSENSING ON A NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD. IT WAS KNOWN THAT FARFIELD OVERSENSING IN A KNOWN ISSUE FOR THIS PATIENT. TS DISCUSSED PROGRAMMING OPTIONS. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THERE IS STILL AN ONGOING ISSUE WITH FARFIELD OVESENSING. ADDITIONALLY, P WAVES ARE NOTED TO BE SMALL THEREFORE, NO PROGRAMMING OPTIONS ARE AVAILABLE. TS ALSO NOTED THERE WAS ATRIAL UNDERSENSING . AT THIS TIME, THE DEVICE AND NON-BOSTON SCIENTIFIC LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24224001 ↗
• InjuryJan 20, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS IN TWO DIFFERENT EPISODES DUE TO ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING OPTIMIZATION WITH THE FIELD REPRESENTATIVE AND THAT IT MIGHT BE BEST TO TRY TO PREVENT THE RVR THROUGH NON DEVICE MEANS. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24119458 ↗
• InjuryJan 20, 2026Pacing Problem; Failure to Convert Rhythm; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED THREE ROUNDS OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND EIGHT INAPPROPRIATE SHOCK(S) DUE TO AN EPISODE OF ATRIAL ARRHYTHMIA. DEVICE EXPERIENCED THERAPY EXHAUSTION. THE DEVICE ACCELERATED THE RHYTHM TO VENTRICULAR FIBRILLATION (VF) AND THERAPY FAILED TO CONVERT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s); Ventricular Fibrillation

  MAUDE report 24117356 ↗
• MalfunctionJan 9, 2026High impedance; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING LOW RIGHT VENTRICULAR (RV) LEAD INTRINSIC AMPLITUDE. ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED TO CONVERT AN ARRHYTHMIA. TECHNICAL SERVICES (TS) WAS CONSULTED AND EXPLAINED NO OVERSENSING OR NOISE WERE PRESENT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS OBTAINED; THE DEVICE IS EXHIBITING PACING IMPEDANCE HIGH OUT RANGE ON THE RIGHT VENTRICULAR (RV) LEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24025550 ↗
• MalfunctionJan 7, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED NOISE DURING NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES. PACING INHIBITION OVER TWO SECONDS WAS ALSO OBSERVED. TECHNICAL SERVICES (TS) WAS CONSULTED AND UPON REVIEW DISCUSSED IT APPEARS TO BE ELECTROMAGNETIC INTERFERENCE (EMI). CLINICAL EVALUATION WILL BE PERFORMED. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 23992259 ↗
• InjuryDec 29, 2025Signal Artifact/Noise; Failure to Read Input Signal; Low impedance; Signal Artifact/Noise; Failure to Read Input Signal; Low impedance

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR ASSISTANCE PROGRAMMING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE RIGHT VENTRICULAR (RV) LEAD INTO MAGNETIC RESONANCE IMAGING (MRI) PROTECTION MODE. TECHNICAL SERVICES (TS) EVALUATED THIS CRT-D FOR PROGRAMMING BUT DIDN'T PROGRAM INTO MRI PROTECTION MODE DUE TO LOW OUT OF RANGE SHOCK LEAD IMPEDANCE MEASUREMENTS OF ONE OHM. TS RECOMMENDED EVALUATING THE RV LEAD AND DISCUSSED THAT PROCEEDING WITH AN MRI WOULD BE NON-CONDITIONAL DUE TO THE LOW SHOCK LEAD IMPEDANCE MEASUREMENT. THIS CRT-D REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. TS REVIEWED DEVICE DATA AND FOUND THE SHOCK LEAD IMPEDANCE HAS BEEN 0, 8, 11, AND 18 OHMS. TS DISCUSSED THIS DID NOT LOOK LIKE NORMAL INTERFERENCE AND SUSPECTED A POSSIBLE SHORT. TS RECOMMENDED THE PATIENT RECEIVE A COMMANDED 41J SHOCK TEST. ADDITIONAL INFORMATION WAS RECEIVED. THE RV LEAD EXHIBITED LOW AMPLITUDES AND NOISE WAS SUSPECTED. TS DISCUSSED PLANNING A COMMANDED SHOCK TO ASSESS LEAD INTEGRITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918174 ↗
• MalfunctionDec 16, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TECHNICAL SERVICES (TS) FOR A CONSULT REVIEW OF THE PRESENTING ELECTROGRAM (EGM) OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. UPON REVIEW, THE PRESENTING EGM SHOWED THE DEVICE EXHIBITED OVERSENSED NOISE ON ALL CHANNELS. IT WAS NOTED THAT THE OVERSENSED NOISE APPEARED TO BE ELECTROMAGNETIC INTERFERENCE (EMI) IN NATURE. THE HCP WILL FOLLOW UP WITH THE DEVICE TREATING CLINICIAN. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23820990 ↗
• MalfunctionDec 9, 2025Signal Artifact/Noise; Over-Sensing; Pacing Problem; Failure to Read Input Signal; Signal Artifact/Noise; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE RIGHT VENTRICULAR (RV) LEAD, AND THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING OF NOISY SIGNALS. THE NOISE ON THE RA CHANNEL WAS SUSPECTED TO BE NON-PHYSIOLOGICAL AND CAUSED INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR). THE NOISE ON THE RV CHANNEL WAS REPRODUCIBLE WITH ISOMETRICS AND CAUSED PACING INHIBITION FOR FOUR TO FIVE SECONDS. IT WAS NOTED THERE WERE LOW AMPLITUDES ON THE RV CHANNEL. TECHNICAL SERVICES (TS) DISCUSSED ADJUSTING SENSING AND RECOMMENDED A DEFIBRILLATION THRESHOLD (DFT) TEST. TS ALSO DISCUSSED THAT THE RV AND RA LEADS WERE FAILING AND RECOMMENDED LEAD REVISIONS. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 23760148 ↗
• MalfunctionDec 9, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A HIGH CAPTURE THRESHOLD WHICH CAUSED A LOSS OF CAPTURE. THIS CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760008 ↗
• InjuryDec 1, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. THIS CRT-D WAS EXPLANTED AND A NEW DEVICE OF DIFFERENT MODEL WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682699 ↗
• MalfunctionOct 23, 2025Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, OVERSENSED NOISY SIGNALS AND INTERMITTENT LOSS OF CAPTURE (LOC) ON THE RIGHT VENTRICULAR (RV) CHANNEL. TECHNICAL SERVICES (TS) WAS CONSULTED AND DETERMINED AND NOTED IT WAS A NON-BOSTON SCIENTIFIC RV LEAD AND SUSPECTED THE ISSUES WERE CAUSED BY A FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375647 ↗
• InjuryOct 20, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, IMPLANTED WITH A NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD, EXHIBITED CONSISTENTLY HIGH, OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS AND LOW R-WAVES. THIS NEARLY 300 EPISODES WERE STORED STARTING IN SEPTEMBER 10 WITH NOISE AND SIGNIFICANT OVERSENSING, THREE BURSTS OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP), AND 23 INAPPROPRIATE SHOCKS. THERAPY WAS NOT EXHAUSTED, AND NORMAL SINUS RHYTHM WAS OBSERVED AFTER EACH SHOCK. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS AND POSSIBLE CAUSES, SUCH AS LEAD FRACTURE. THERE WAS APPROXIMATELY 11 MONTHS REMAINING ON THE BATTERY, AND THE LEAD REVISION MAY BE CONSIDERED AT THE UPCOMING DEVICE CHANGEOUT. THIS CRT-D SYSTEM REMAINS IN SERVICE. NO INTERVENTIONS OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344350 ↗
• InjurySep 23, 2025Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Low impedance; Signal Artifact/Noise; Failure to Capture; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal; Low impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED DRAMATIC OVERSENSING ON THE RIGHT VENTRICULAR (RV) CHANNEL. OVERSENSING OF NOISE RESULTED IN PACING INHIBITION GREATER THAN FIVE SECONDS. OVERSENSING RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING AND A SINGLE INAPPROPRIATE SHOCK TO BE DELIVERED. TECHNICAL SERVICES (TS) ADVISED AMPLITUDES ARE LOW AND LOSS OF CAPTURE WAS EXHIBITED ON THE PRESENTING ELECTROGRAM. IN ADDITION, TS FOUND INTERMITTENT HIGH OUT OF RANGE RIGHT ATRIAL (RA) PACING IMPEDANCE MEASUREMENTS. HOWEVER, RA PACING IMPEDANCE MEASUREMENTS ARE NOW GRADUALLY DECREASING BUT REMAIN WITHIN RANGE. A GRADUAL RISE IN RV SHOCK IMPEDANCE MEASUREMENTS WAS ALSO OBSERVED. HOWEVER, SHOCK IMPEDANCE MEASUREMENTS REMAINED WITHIN NORMAL LIMITS AT THIS TIME. A TEMPORARY PACEMAKER WAS USED. THIS CRT-D WAS SUBSEQUENTLY EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THIS CRT-D HAS NOT BEEN RETURNED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole; Shock from Patient Lead(s)

  MAUDE report 23126472 ↗
• MalfunctionSep 16, 2025High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LEFT VENTRICULAR SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 200 OHMS. TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING CHANGES. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064478 ↗
• InjuryAug 28, 2025Defibrillation/Stimulation Problem; Inaccurate Synchronization; Inaccurate Synchronization

  IT WAS REPORTED THAT AFTER THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROVIDED APPROPRIATE ANTI-TACHYCARDIA PACING (ATP), THE RHYTHM ACCELERATED INTO FAST VENTRICULAR TACHYCARDIA (VT). THERE WAS ALSO A SLIGHTLY DELAYED THERAPY RESPONSE DUE TO THE ARRHYTHMIA STARTING IN THE VT MONITOR ONLY ZONE. THE ATP AND SHOCKS HAD SUCCESSFULLY CONVERTED THE PATIENT'S ARRHYTHMIAS, AND THE PATIENT WAS SEEN IN THE EMERGENCY ROOM. TECHNICAL SERVICES (TS) DISCUSSED OPTIMIZATION SETTINGS. THIS CRT-D REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Shock from Patient Lead(s); Tachycardia

  MAUDE report 22919065 ↗

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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-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-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-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-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.