DYNAGEN™ EL ICD VR D151Recalls & reported problems

Summary

The FDA's MAUDE database contains 413 adverse event reports that list this exact device (DI 00802526534300), received between Apr 15, 2016 and Sep 29, 2026 — classified as 4 deaths, 206 injuries, 203 malfunctions.

The most frequently reported specific device problem is “High impedance” (222 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 413 reports, 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 ↗
• 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 ↗
• 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 8, 2026Off-Label Use; Connection Problem; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673660 ↗
• MalfunctionAug 20, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360111 ↗
• MalfunctionAug 20, 2026Premature Discharge of Battery

  It was reported that this implantable cardioverter defibrillator (ICD) recorded a Code 1003, which states that the voltage is too low for projected remaining capacity. A request was made to have data from this device analyzed. Data analysis identified that the power consumption is increasing in a gradual fashion. Device replacement was recommended. This device remains in service at this time. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50335465 ↗
• MalfunctionAug 20, 2026Signal Artifact/Noise; Over-Sensing; High Capture Threshold

  It was reported that electrogram (EGM) review of this implantable cardioverter defibrillator (ICD) system revealed possible electromagnetic interference (EMI) noise with oversensing and elevated threshold measurements on the right ventricular (RV) defibrillation lead. There was no evidence of pacing inhibition or asystole, as intrinsic conduction was observed through the noise. Shock impedance trends showed a gradual increase in measurements from 50 to 70 Ohms over the last seven years, consistent with calcification. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50335403 ↗
• InjuryAug 3, 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 the battery voltage recently began dropping in an irregular fashion. Device replacement was recommended. This ICD was explanted, replaced with a different model and returned for analysis. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50124122 ↗
• MalfunctionJul 29, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50077774 ↗
• MalfunctionJul 28, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Low impedance; Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052308 ↗
• MalfunctionJul 8, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A RED CALL DOCTOR (RCD). TROUBLESHOOTING WAS PERFORMED. THE RCD RECORDED WAS FOR HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25757228 ↗
• MalfunctionJul 7, 2026Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Battery Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A LOW VOLTAGE FAULT CODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONFIRMED THE POWER CONSUMPTION HAD BEEN INCREASING IN A GRADUAL FASHION, CONSISTENT WITH CAPACITOR DEGRADATION DUE TO HYDROGEN GAS CONTAINED IN THE SEALED PULSE GENERATOR ATMOSPHERE, AND REFERRED THE PATIENT TO CLINIC AND SUGGESTED TO DISABLE THE BEEPER. ADDITIONAL INFORMATION WAS RECEIVED INDICATING A RED CALL DOCTOR (RCD) ALERT ALSO APPEARED ON THE COMMUNICATOR. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25741904 ↗
• MalfunctionJun 23, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED OVERSENSING OF NOISY SIGNALS FOR ITS NON BOSTON SCIENTIFIC 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 25596270 ↗
• MalfunctionJun 15, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A SUDDEN SPIKE IN SHOCK IMPEDANCE MEASUREMENTS REACHING HIGHER THAN 200 OHMS. TECHNICAL SERVICES (TS) WAS CONTACTED AND REVIEWED THE INFORMATION AVAILABLE. THIS SYSTEM WAS REPROGRAMMED. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25513274 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO UNKNOWN REASONS. THIS ICD WAS SUCCESSFULLY REPLACED, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000174 ↗
• MalfunctionApr 23, 2026High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES WITH VALUES GREATER THAN 200 OHMS IN THE RIGHT VENTRICULAR (RV) CHANNEL. TECHNICAL SERVICES (TS) WAS CONTACTED AND PROVIDED FURTHER EVALUATION RECOMMENDATIONS. FURTHERMORE, IT WAS REPORTED THAT REPROGRAMMING TO A DIFFERENT IMPEDANCE VECTOR WAS PERFORMED AND CONTINUOUS MONITORING WAS GOING TO BE PROVIDED. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972071 ↗
• InjuryJan 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO UNKNOWN REASONS AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. FURTHER INFORMATION REGARDING PRODUCT RETURN STATUS HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24218162 ↗
• MalfunctionJan 28, 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 USING TRIAD CONFIGURATION VECTOR. THE RV LEAD CONFIGURATION VECTOR WAS CHANGED AND THE SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN RANGE. TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED STORED DATA, WITH TS SUGGESTING THE PHYSICIAN TO CONSIDER A DEFIBRILLATION THRESHOLD (DFT) DEFIBRILLATION THRESHOLD (DFT) TEST ON THE NEW VECTOR IF THEY DESIRED. THIS DEVICE REMAINS IN SERVICER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200910 ↗
• InjuryJan 23, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003, WHICH STATES THAT THE VOLTAGE IS TOO LOW FOR 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 OR REEVALUATION OF BATTERY STATUS WAS RECOMMENDED. TO DATE, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162307 ↗
• MalfunctionDec 29, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A HEARTRATE OF 37 BEATS PER MINUTE (BPM) ON EXTERNAL TELEMETRY, HOWEVER, THE DEVICE DID NOT PROVIDE PACING. THE LOWER RATE LIMIT IS PROGRAMMED TO 40 BPM. TECHNICAL SERVICES (TS) CONFIRMED THE LIMIT IS SET TO 40 BPM AND OFFERED THE POSSIBILITY THAT THE EXTERNAL TELEMETRY IS NOT ACCURATE. AT THIS TIME, THIS ICD REMAINS IN SERVICE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 23916946 ↗
• InjuryDec 29, 2025Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. MOREOVER, THE DEVICE EMITTED BEEPING TONES. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED LOW VOLTAGE FAULT AND THAT THIS DEVICE POWER CONSUMPTION IS INCREASING IN A GRADUAL FASHION. A DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23904177 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse 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 23672062 ↗
• InjuryNov 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) MAY BE TURNED OFF, WHICH RAISED CONCERNS FROM THE PATIENT ADVOCATE. THE TECHNICAL SERVICES (TS) CONSULTANT RECOMMENDED COORDINATING WITH THE CLINIC STAFF AND INQUIRED WHETHER A HEALTHCARE PROFESSIONAL (HCP) COULD BE PRESENT DURING THE DEVICE CHECK. AT THIS TIME, THE ICD REMAINS ACTIVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658602 ↗
• DeathNov 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Defibrillation/Stimulation Problem; Low impedance; Incorrect, Inadequate or Imprecise Result or Readings; Defibrillation/Stimulation Problem; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD DISPLAYED A CODE 1004 WHICH IS INDICATIVE OF A SHORT CIRCUIT CONDITION WAS DETECTED DURING SHOCK DELIVERY, IN ADDITION TO SHOCK IMPEDANCE MEASUREMENTS OF LESS THAN 20 OHMS. SUBSEQUENT SHOCKS WERE ABORTED DUE TO HIGH VOLTAGE DETECTED ON THE LEAD. ULTIMATELY, THIS PATIENT EXPIRED.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623768 ↗

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-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