DYNAGEN™ EL ICD VR D150Recalls & reported problems

Summary

The FDA's MAUDE database contains 831 adverse event reports that list this exact device (DI 00802526534287), received between Apr 22, 2016 and Sep 28, 2026 — classified as 8 deaths, 551 injuries, 272 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (147 reports).

14 other recalls cover devices cleared under the same FDA submission (P960040); 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 831 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 4, 2026Premature Discharge of Battery; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50602420 ↗
• MalfunctionSep 4, 2026Over-Sensing; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600874 ↗
• MalfunctionAug 18, 2026High impedance; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50306527 ↗
• MalfunctionAug 12, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter-defibrillator (ICD) recorded Code 1003, indicating that the battery voltage was too low for the projected remaining capacity. The device data were analyzed, and it was determined that the power consumption is increasing in a gradual fashion. The pulse generator should either be replaced or have its battery status reevaluated within 180 days. To date, the device remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225916 ↗
• MalfunctionJul 31, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) recorded a 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 that the power consumption was increasing in a gradual fashion. Device replacement was recommended. As of this time, this ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50104573 ↗
• InjuryJul 29, 2026Defibrillation/Stimulation Problem

  It was reported that this implantable cardioverter defibrillator (ICD) didn't provide successful shocks for the patient's ventricular tachycardia (VT). Technical Services (TS) reviewed device data and confirmed there were no reverse polarity shocks and no therapy exhaustion. TS also confirmed there were inconsistent and unsuccessful shocks. At the beginning of the VT episode, a shock was provided that slowed the rhythm below the rate cut off. The rhythm went back to VT, and three shocks were provided that were unsuccessful. The fourth shock accelerated the arrhythmia to ventricular fibrillation (VF). The fifth shock converted the rhythm. The rhythm went back to VT, and a shock was provided which accelerated the arrythmia to VF again. The second shock was unsuccessful, and the third shock converted the arrhythmia. TS recommended performing a defibrillation threshold (DFT) test and adjusting therapy zones as a non-invasive option. A DFT was performed and was successful. The plan was to implant a superior vena cava (SVC) coil. A dual coil right ventricular (RV) lead was implanted. This ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50069853 ↗
• MalfunctionJul 9, 2026Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LONGEVITY DROPPED FROM 9 YEARS TO OF 7.5 YEARS IN A SPAN OF 3 MONTHS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT PATIENT HAD MAGNETIC RESONANCE IMAGING DONE. TS SUGGESTED TO HAVE A PATIENT INITIATED INTERROGATION (PII) AND RE-EVALUATION IN A MONTH. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773992 ↗
• MalfunctionJul 7, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ONE INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THAT THE PATIENT DID NOT HAVE AN ATRIAL LEAD, MAKING DETERMINATION OF THE RHYTHM ORIGIN MORE CHALLENGING. HOWEVER, IT WAS ALSO NOTED THAT THE PATIENT HAD A DOCUMENTED HISTORY OF AF EPISODES. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25736775 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25686120 ↗
• InjuryJul 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF THE SYSTEM REVISION DUE TO INFECTION AND SEPSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25676735 ↗
• MalfunctionJun 30, 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. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED. AT THIS TIME, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673479 ↗
• MalfunctionJun 29, 2026Pacing Problem

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) REQUESTED A REVIEW OF REPORTS FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE HCP NOTED THE ICD EXHIBITED PACING INHIBITION AND HAD QUESTIONS REGARDING THE THERAPY DELIVERED AFTER. TECHNICAL SERVICES (TS) REVIEWED THE DATA AND NOTED THE EPISODE SHOWED A FAST ONSET OF POSSIBLE SUPRAVENTRICULAR TACHYCARDIA (SVT) WHICH ACCELERATED INTO THE VENTRICULAR FIBRILLATION (VF) ZONE. TS DISCUSSED QUICK CONVERT WAS DELIVERED AND SUCCESSFULLY TERMINATED THE ARRHYTHMIA. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Bradycardia

  MAUDE report 25654081 ↗
• InjuryJun 19, 2026Failure to Convert Rhythm

  IT WAS REPORTED THAT DURING IMPLANT PROCEDURE THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM FAILED DEFIBRILLATION THRESHOLD (DFT) TESTING AS A RESULT, THE PHYSICIAN MADE THE DECISION TO USE AN ADDITIONAL COIL AND REPROGRAM POLARITY. IT WAS NOTED THAT THIS SYSTEM WAS PLACED IN A HEALTHY AMOUNT OF ADIPOSE TISSUE. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567824 ↗
• MalfunctionJun 17, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS FOR ITS RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25536377 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25383163 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960040. One submission often covers many models, so check the product and lot details in each record.

• Z-1670-2022 · 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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, 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-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• Z-1555-2010 · Mar 15, 2010 · Terminated
  Boston Scientific CONFIENT, model E030, Implantable Cardioverter Defibrillator (ICD). The CONFIENT Implantable Cardioverter Defibrillator (ICDs) are designed to detect and termina
• Z-0610-2010 · Dec 1, 2009 · Terminated
  Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethyle
• Z-1621-2009 · Mar 4, 2009 · Terminated
  GUIDANT VITALITY DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardi
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-0050-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY DS DR/VR (Models T125, T135), Guidant VITALITY EL (Model T127), Guidant VITALITY DR HE (Model T180), Implantable Cardioverter Defibrillators (ICD). Guidant Corpor
• Z-0051-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY 2 DR/VR (Models T165, T175) and Guidant VITALITY 2 EL DR/VR (Models T167, T177). Implantable Cardioverter Defibrillator, ICD. Guidant Corporation, 4100 Hamline A
• Z-1297-06 · Jun 24, 2006 · Terminated
  Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide.
• Z-1292-06 · May 15, 2006 · Terminated
  Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125), VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ven
• Z-0828-06 · Apr 7, 2006 · Terminated
  Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 551