DYNAGEN EL ICD DRRecalls & reported problems across all models

We found 2 models of DYNAGEN EL ICD DR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,094 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Sep 28, 2026 — classified as 16 deaths, 1,149 injuries, 929 malfunctions.

The most frequently reported specific device problem is “High impedance” (541 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 EL ICD DR problems

DYNAGEN EL ICD DR models

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

• DYNAGEN™ EL ICD DR D152

  Implantable cardioverter defibrillator (non-CRT)
  12 deaths1,208 reports
• DYNAGEN™ EL ICD DR D153

  Implantable cardioverter defibrillator (non-CRT)
  4 deaths886 reports

Recent DYNAGEN EL ICD DR adverse event reports

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

• MalfunctionSep 28, 2026Failure to Convert Rhythm; Under-Sensing; Low impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system required six shocks to convert ventricular fibrillation (VF) and exhibited low shock impedance measurements of 80 Ohms. Additionally, undersensing was also observed. It was noted that the undersensing did not cause the difficulty to convert. The patient was reported to have low potassium levels and to experience acute heart failure which the physician believed contributed to the failed shocks. Technical Services (TS) was contacted and after reviewing the available information, noted that the Ohm range available was sufficient to convert. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916969 ↗
• InjurySep 25, 2026Failure to Convert Rhythm

  Patient problems: Ventricular Fibrillation

  MAUDE report 50898086 ↗
• InjurySep 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate shocks and anti-tachycardia pacing (ATP) for what appeared to be atrial fibrillation (AF) with rapid ventricular response (RVR). No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50882566 ↗
• MalfunctionSep 23, 2026Failure to Convert Rhythm; Under-Sensing

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) had three separate ventricular tachycardia (VT) episodes and therapy was exhausted in two of the episodes. Additionally, this ICD exhibited undersensing. Technical Services (TS) reviewed the data and noted therapy was appropriate and that there was some rare undersensing. TS noted the undersensing did not impact the time to delivery therapy. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871534 ↗
• InjurySep 22, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50862595 ↗
• MalfunctionSep 9, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50697765 ↗
• MalfunctionSep 9, 2026Inappropriate/Inadequate Shock/Stimulation; Interrogation Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50697401 ↗
• InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 50652160 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) emitted beeping tones due to the recorded Code 1003, indicating the voltage was too low for the projected remaining capacity. A request was made to have data from this device analyzed. Data analysis showed the battery voltage recently began dropping in an irregular fashion. Device replacement was recommended. As of this time, this ICD remains in service. No adverse patient effects were reported.Additional information indicated that this ICD was explanted and replaced with the same model. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602476 ↗
• InjurySep 4, 2026Insufficient Device Problem Information

  It was reported that this implantable cardioverter defibrillator (ICD) was explanted due to an unspecified reason. The physician noted this ICD was explanted due to "ventricular tachycardia (VT)" with no further information available. This ICD was explanted and returned for analysis. No additional adverse patient effects were reported.

  Patient problems: Tachycardia

  MAUDE report 50602161 ↗
• MalfunctionSep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50602096 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602060 ↗
• MalfunctionSep 4, 2026Device Alarm System; Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600740 ↗
• MalfunctionSep 4, 2026High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600638 ↗
• InjuryAug 25, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) system exhibited an alert for high pacing impedance measurements above 3000 Ohms. This device has been explanted and replaced. No additional adverse patient effects were reported. This device has not been returned for analysis.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50425856 ↗

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