DYNAGEN™ EL ICD DR D152Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,208 adverse event reports that list this exact device (DI 00802526534324), received between Apr 21, 2016 and Sep 25, 2026 — classified as 12 deaths, 755 injuries, 441 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (252 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 1,208 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Implant Pain

  MAUDE report 50602096 ↗
• 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 ↗
• InjuryAug 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered one burst of anti-tachycardia pacing (ATP) and seven shocks as inappropriate therapy for atrial fibrillation (AF) with rapid ventricular response (RVR). Technical Services (TS) was consulted and discussed stored as well as programming options based on the patients rhythm. Additionally, the patient reported that the device felt warm and hot intermittently. TS performed an analysis of device battery and it was determined the battery was depleting normally, with power consumption stable. The device function is normal since high power events would be reflected in power consumption or monitoring voltage, with both normal and no device issues noted. This device remains in service. No additional adverse patient effects were reported.

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

  MAUDE report 50416011 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this implantable cardioverter defibrillator (ICD) was explanted with less than a month of use as the patient had swelling in the left arm due to an unknown cause and a subclavian vein thrombosis was suspected. No new device was implanted. No additional adverse patient effects were reported.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 50360699 ↗
• MalfunctionAug 20, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered nine bursts of anti-tachycardia pacing (ATP) and one shock as inappropriate therapy for a suspected atrial driven rhythm. Technical Services (TS) was consulted and discussed stored data. This device remains in service. No adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50351098 ↗
• InjuryAug 20, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the patient implanted with this implantable cardioverter defibrillator (ICD) received two inappropriate shocks for two episodes of atrial fibrillation (AF) with rapid ventricular response (RVR). Therapy was not exhausted. Technical Services (TS) was consulted about the episodes while the patient was getting an AF ablation. This ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50349152 ↗
• MalfunctionAug 19, 2026Over-Sensing

  Patient problems: Insufficient Information

  MAUDE report 50326224 ↗
• InjuryAug 13, 2026Signal Artifact/Noise

  It was reported that implantable cardioverter defibrillator (ICD) exhibited noisy signals on reviewed electrograms. Technical Services (TS) confirmed the noise on the presenting electrogram. The device was unexpectedly received by Boston Scientific for further analysis. No new device has been implanted. No additional adverse patient effects were reported. This ICD is no longer in service.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234769 ↗
• MalfunctionAug 12, 2026Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50223120 ↗
• MalfunctionAug 11, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50214636 ↗
• MalfunctionAug 11, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211012 ↗
• MalfunctionAug 11, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204422 ↗
• MalfunctionAug 11, 2026Pacing Problem; Failure to Read Input Signal; Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50204134 ↗
• InjuryAug 4, 2026Over-Sensing; Pacing Problem; Failure to Convert Rhythm; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered inappropriate anti-tachycardia pacing (ATP) and five electric shocks due to sinus tachycardia. The rate started with a 1:1 rhythm with a high Rhythm ID (RID) match, then RID became negative which led to the inappropriate therapy. The ATP accelerated the ventricular tachycardia (VT) into the ventricular fibrillation (VF) zone. The rhythm went from VF to VT several times during the five shocks. Therapy was exhausted and didn't convert the arrythmia. Also, it was noted there was intermittent atrial oversensing of ventricular signals. Technical Services (TS) recommended reprogramming options. This ICD remains in service. No additional adverse patient effects were reported.

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

  MAUDE report 50133105 ↗
• MalfunctionAug 4, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50129766 ↗
• InjuryJul 31, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Under-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) exhibited undersensing that resulted in three inappropriate shocks and anti-tachycardia pacing (ATP) delivered when not required. Technical Services (TS) was consulted and faxed the results for the health care professional (HCP) to review. This device remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50100693 ↗
• InjuryJul 27, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered six shocks and several rounds of anti-tachycardia pacing (ATP) for what appeared to be atrial fibrillation (AF) with rapid ventricular response (RVR). Technical Services (TS) was contacted and reviewed the information. This ICD remains in service. No additional adverse patient effects were reported.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50047568 ↗

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-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, 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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, 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-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• 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-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-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