DYNAGEN CRT-DRecalls & reported problems across all models

We found 3 models of DYNAGEN CRT-D by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,093 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2016 and Sep 15, 2026 — classified as 6 deaths, 633 injuries, 454 malfunctions.

The most frequently reported specific device problem is “High impedance” (321 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DYNAGEN CRT-D problems

DYNAGEN CRT-D models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DYNAGEN™ CRT-D G151

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths533 reports
• DYNAGEN™ CRT-D G150

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 deaths410 reports
• DYNAGEN™ CRT-D G154

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death150 reports

Recent DYNAGEN CRT-D adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Insufficient Device Problem Information

  It was reported that the defibrillation of this cardiac resynchronization therapy defibrillator was turned off. The patient is coordinating with the clinic. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775491 ↗
• MalfunctionSep 14, 2026Over-Sensing

  It was reported that this cardiac resynchronization therapy defibrillator (CRT-D) recorded episodes of inappropriate Atrial Tachy Responses (ATRs) and far field over sensing. It was recommended to measure the far field signal on programmer and considering the decrease of sensing. Also changing the blanking setting from smart to fixed and extending ATR duration was recommended. There were no impacts to patient. No adverse patient effects were reported. The CRT-D remains in service at this time.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754464 ↗
• MalfunctionSep 10, 2026Failure to Capture; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722421 ↗
• MalfunctionSep 10, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50703251 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the health care professional (HCP) called Technical Services (TS) regarding this cardiac resynchronization therapy defibrillator (CRT-D) system. The HCP noted this CRT-D had recently been explanted due to unknown reasons, however part of the lead was broken during the explant procedure and left behind. The HCP was asking TS about magnetic resonance imaging (MRI). TS discussed any fractured or broken lead would be non-conditional. No additional adverse patient effects were reported. This CRT-D has not been returned for analysis.Additional information was received and it was reported that this CRT-D was explanted due to a vegetation on the right ventricular (RV) lead. No additional adverse patient effects were reported. This CRT-D has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690740 ↗
• InjurySep 4, 2026Failure to Read Input Signal; Under-Sensing

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) was evaluated on an in-clinic visit. An issue with the Non-Boston Scientific left ventricular (LV) and right atrial (RA) leads was identified, and the device was subsequently reprogrammed for right ventricular (RV) only. Technical Services (TS) reviewed the presenting electrogram (EGM) and determined that the device was undersensing P waves. TS recommended reprogramming options. No adverse patient effects were reported. This CRT-P remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616744 ↗
• InjurySep 4, 2026Failure to Convert Rhythm; Unexpected Therapeutic Results

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) experienced a sudden cardiac arrest (SCA). It was noted that all programmed therapy was exhausted during the event. Technical Services (TS) was consulted, and it was reported that the local company representative planned to perform a Consult transmission to obtain the stored episodes for further review. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Cardiac Arrest

  MAUDE report 50602083 ↗
• MalfunctionSep 3, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Failure to Read Input Signal

  Patient problems: Bradycardia

  MAUDE report 50599380 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient with this cardiac resynchronization therapy defibrillator (CRT-D) had an infection. Upon operation, the device pocket was with erythema, hematoma and reddish capsule. A revision was performed and the CRT-D with the right ventricular (RV) lead, right atrial (RA) lead and left ventricular (LV) lead were explanted. A previously capped LV lead remains capped. Subsequently, antibiotic irrigation of the areas was performed. No additional adverse patient effects were reported. The device was not returned for analysis.

  Patient problems: Erythema; Hematoma; Unspecified Infection

  MAUDE report 50368213 ↗
• MalfunctionAug 4, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Device Sensing Problem

  Patient problems: Asystole

  MAUDE report 50132777 ↗
• MalfunctionJul 30, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50091730 ↗
• MalfunctionJul 2, 2026Failure to Capture; High impedance; Pacing Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED A SUDDEN RISE ON PACING IMPEDANCE MEASUREMENTS, REACHING HIGH OUT OF RANGE VALUES GREATER THAN 3000 OHMS ON THE LEFT VENTRICULAR (LV) CHANNEL. TECHNICAL SERVICES (TS) RECOMMENDED PROGRAMMING ENHANCEMENTS. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25700154 ↗
• MalfunctionJul 1, 2026High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-D) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS., ON THE RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) CONFIRMED THIS REPRESENTS A SUDDEN INCREASE. TS RECOMMENDED REPROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT IT IS PLANNED TO EVALUATE THE PATIENT IN SIX MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678066 ↗
• MalfunctionJun 25, 2026Failure to Capture

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED REVIEW OF THE DEVICE DATA DUE TO CONCERNS FOR POSSIBLE LEFT VENTRICULAR (LV) LOSS OF CAPTURE (LOC). TECHNICAL SERVICES (TS) REVIEWED THE RECENT PRESENTING ELECTROGRAM (EGM) AND DETERMINED IT APPEARED CONSISTENT WITH LV LOC. THE HCP INDICATED THAT THE PATIENT WOULD BE BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LV LEAD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25631396 ↗
• MalfunctionJun 25, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED OVERSENSED NOISE ON THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD, RESULTING IN THE INAPPROPRIATE STORAGE OF ATRIAL TACHY RESPONSE (ATR) EPISODES. ADDITIONALLY, WITHIN-RANGE FLUCTUATIONS IN RA IMPEDANCE MEASUREMENTS WERE OBSERVED. TECHNICAL SERVICES (TS) RECOMMENDED PERFORMING A LEAD EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS CRT-D REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621301 ↗

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