DYNAGEN EL ICD VRRecalls & reported problems across all models

We found 2 models of DYNAGEN EL ICD VR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 1,244 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2016 and Sep 29, 2026 — classified as 12 deaths, 757 injuries, 475 malfunctions.

The most frequently reported specific device problem is “High impedance” (359 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 VR problems

DYNAGEN EL ICD VR models

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

• DYNAGEN™ EL ICD VR D150

  Implantable cardioverter defibrillator (non-CRT)
  8 deaths831 reports
• DYNAGEN™ EL ICD VR D151

  Implantable cardioverter defibrillator (non-CRT)
  4 deaths413 reports

Recent DYNAGEN EL ICD VR adverse event reports

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

• InjurySep 29, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50941344 ↗
• MalfunctionSep 28, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) and the right ventricular (RV) lead exhibited a high out of range shock impedance measurement at 129 Ohms. The shock impedance was back to baseline and was in normal limits. No other lead measurements were out of range. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917017 ↗
• InjurySep 28, 2026Failure to Convert Rhythm; Defibrillation/Stimulation Problem; Under-Sensing

  It was reported that the patient with this implantable cardioverter defibrillator (ICD) experienced a ventricular arrhythmia episode. It was noted that the patient initially presented with ventricular tachycardia (VT) and received shock therapy. Following the shock, the rhythm degenerated into ventricular fibrillation (VF). During the VF episode, intermittent undersensing was observed; however, the device ultimately detected the arrhythmia and delivered all available shock therapies. Despite therapy delivery, the arrhythmia was not terminated, and therapy was exhausted. The patient subsequently required external defibrillation to restore rhythm. Technical Services (TS) was consulted and provided reprogramming recommendations for consideration. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50910784 ↗
• InjurySep 25, 2026Pacing Problem; Failure to Convert Rhythm; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

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

  MAUDE report 50903935 ↗
• MalfunctionSep 25, 2026High impedance

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited high out of range shock impedance measurements on the right ventricular (RV) lead. Technical Services (TS) discussed considering intervention. It was noted the patient would be seen at the end of October to replace the lead. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897493 ↗
• MalfunctionSep 15, 2026High impedance

  It was reported that the health care professional (HCP) called Technical Services (TS) for assistance with programming this implantable cardioverter defibrillator (ICD) into magnetic resonance imaging (MRI) protection mode. TS confirmed this ICD system was MRI conditional. Prior to the MRI, the shock impedance measurements appeared to be high out of range. The HCP opted to continue with the MRI. The MRI was successfully completed and the HCP called TS back to confirm the device was out of MRI protection mode. TS confirmed all measurements were within normal limits. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774828 ↗
• MalfunctionSep 15, 2026Signal Artifact/Noise; Failure to Read Input Signal; Under-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited undersensing. It was noted the patient had a left ventricular assist device (LVAD) and that appeared to be causing the undersensing. TS reviewed the data and noted there was noise, but the noise was not oversensed. Additionally, TS noted the pump noise was larger in comparison to the R wave amplitude being small. TS discussed this could happen due to deoxyribonucleic acid (DNA). It was noted the patient followed up with an electrophysiologist (EP) and no changes were made to programming, as the EP did not feel programming changes were needed at this time. No adverse patient effects were reported. This ICD remains in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772882 ↗
• InjurySep 11, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  It was reported that during a defibrillation threshold (DFT) test this implantable cardioverter defibrillator (ICD) system recorded a Code 1005, indicative of an open circuit condition. A commanded shock was delivered and high out of range shock impedance measurements greater than 125 Ohms were detected. As a result, the right ventricular (RV) lead was capped and replaced, and this ICD was explanted and replaced due to RV lead compatibility. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732548 ↗
• MalfunctionSep 10, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717151 ↗
• MalfunctionSep 10, 2026Over-Sensing

  It was reported that the healthcare professional (HCP) for the patient with this implantable cardioverter defibrillator (ICD) contacted Technical Services (TS) regarding a large signal observed during a ventricular episode. TS reviewed the available data and noted that the signal appeared consistent with Cardiac Contractility Modulation (CCM) therapy, which would not be unexpected if a CCM system were implanted. The HCP was unable to confirm whether the patient had a CCM device. TS further noted that the signal was intermittently oversensed; however, it occurred within the device's blanking period and therefore did not affect timing cycles or result in a device response. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50707404 ↗
• MalfunctionSep 8, 2026Premature Discharge of Battery; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50679192 ↗
• MalfunctionSep 8, 2026Off-Label Use; Connection Problem; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673660 ↗
• InjurySep 7, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50657357 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616907 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) recorded a Code 1003, indicating the voltage is too low for the projected remaining capacity. Technical Services (TS) was consulted on how to proceed since the device was found to be in storage mode. TS advised on explanting and replacing this device. This device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602464 ↗

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