DYNAGEN™ MINI ICD VR D021Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00802526533884), received between Apr 21, 2016 and May 21, 2025 — classified as 25 injuries, 19 malfunctions.

The most frequently reported specific device problem is “High impedance” (16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED LOW VOLTAGE FAULT AND THAT THIS DEVICE BATTERY VOLTAGE RECENTLY BEGAN DROPPING IN AN IRREGULAR FASHION. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED. A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058305 ↗
• InjuryJul 24, 2024Adverse 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 EXPLANTED TO UNKNOWN ISSUE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813442 ↗
• MalfunctionApr 8, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD AN ALERT INDICATING THAT THERE WAS AN OUT OF RANGE PACING IMPEDANCE VALUE ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. TECHNICAL SERVICES (TS) REVIEWED THE REPORTS AND ADVISED MONITORING THE ISSUE AS THE IMPEDANCE VALUES WERE SLIGHTLY BELOW THE NOMINAL UPPER LIMIT. TS NOTED THERE WERE NO NOISY SIGNALS IN THE LOGBOOK OR IN THE PRESENTING. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19067189 ↗
• InjuryApr 4, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SEVEN INAPPROPRIATE SHOCKS DUE TO A SUPRAVENTRICULAR TACHYCARDIA (SVT). THERAPY WAS NOT EXHAUSTED AS THIS WAS THROUGH MULTIPLE EPISODES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19048016 ↗
• MalfunctionOct 27, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POTENTIALLY DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY DUE TO SUPRAVENTRICULAR TACHYCARDIA (SVT). THE PATIENT'S RHYTHM WAS CONVERTED. THE DEVICE REMAINS IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 18020246 ↗
• InjuryAug 21, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED AN FC 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THIS DEVICE WAS SUBMITTED FOR ENGINEERING ANALYSIS WHICH RESULTED THAT THIS DEVICE EXHIBITED A LOW VOLTAGE. THERE WERE NO OTHER SUSPICIOUS FAULTS OR RESETS STORED WITHIN DEVICE MEMORY. THE BATTERY VOLTAGE AT THE TIME OF INTERROGATION WAS 3.024 VOLTS, THERAPY DELIVERY WAS UNAFFECTED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THAT THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586630 ↗
• InjuryMay 15, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. DATA ANALYSIS SHOWED THAT THE BATTERY DIAGNOSTICS SHOWS RANDOM, INTERMITTENT, UNPREDICTABLE BEHAVIOR, CONSISTENT WITH A DEVICE MALFUNCTION. RECOMMENDED DEVICE EXPLANT AND REPLACEMENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936326 ↗
• InjuryMay 8, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR CHANNEL. NO CHANGES HAVE BEEN PERFORMED AS THE PATIENT HAS BEEN SCHEDULED FOR A THERAPY UPGRADE IN THE FUTURE. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891904 ↗
• MalfunctionFeb 3, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS, MEASURING 130 OHMS. THE PHYSICIAN RECONNECTED THE LEAD AND NOW IS GETTING A SHOCK LEAD IMPEDANCE MEASURING 60 OHMS. AT THIS TIME, THE ICD AND RV LEAD REMAINS IN SERVICE NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292676 ↗
• InjuryDec 8, 2022Adverse 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 15940894 ↗
• MalfunctionOct 20, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT CLAIMS RECEIVED 27 INAPPROPRIATE SHOCKS. AT THIS TIME THERE IS NO MORE INFORMATION AVAILABLE. PRODUCT INVESTIGATION WILL BE PERFORMED TO HAVE FURTHER INFORMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 15644850 ↗
• MalfunctionSep 5, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH PACING IMPEDANCE OUT OF RANGE IN THE NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. TECHNICAL SERVICES (TS) RECOMMENDED TO MONITOR THE LEAD INTEGRITY REMOTELY. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15357715 ↗
• InjuryJul 18, 2022Signal Artifact/Noise; High impedance; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD) DELIVERED SOME ELECTRIC SHOCKS. IT WAS SUSPECTED THAT THIS PATIENT WAS IN SINUS RHYTHM. TECHNICAL SERVICES (TS) WAS CONSULTED AND PROVIDED TROUBLESHOOTING SUGGESTIONS. THE ICD TRIED TO BE INTERROGATED. UNFORTUNATELY, IT WAS FOUND THAT THE REMOTE MONITORING CAPABILITIES HAD BECOME DISABLED DUE TO LIMITED BATTERY CAPACITY ONCE THE ICD REACHED THE END OF LIFE (EOL). FURTHER REVIEW OF THIS ICD DATA REVEALED THAT ANTI-TACHYCARDIA PACING (ATP) THERAPY WAS DELIVERED TO CONVERT THE ARRHYTHMIA. ADDITIONALLY, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS, OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS, AND NOISY SIGNALS WERE ALSO OBSERVED. ICD SYSTEM REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE ICD AND THE NON-BOSTON SCIENTIFIC LEAD WERE EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 15048551 ↗
• MalfunctionMay 27, 2022Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS SYSTEM EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 3000 OHMS AND INTERMITTENT LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE PATIENT WAS BROUGHT INTO THE CLINIC AND TESTING CONFIRMED NORMAL IMPEDANCE MEASUREMENTS AND STABLE THRESHOLD MEASUREMENTS. THE RV PACING OUTPUT WAS INCREASED. IT WAS NOTED THAT THE LEAD IN QUESTION IS MANUFACTURED BY A COMPETITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14529847 ↗
• InjuryApr 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED SEPSIS. ALL AVAILABLE INFORMATION INDICATES THAT AS OF THIS TIME, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN SERVICE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 14191252 ↗
• MalfunctionApr 21, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED WITH ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, TRIGGERED A RED ALERT VIA PATIENT REMOTE MONITORING DUE TO A HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. THE PATIENT WAS SEEN IN THE HOSPITAL FOR A DEVICE CHECK, AND THE HIGH PACE IMPEDANCE MEASUREMENTS WERE NOT REPRODUCIBLE. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14177559 ↗
• InjuryApr 9, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED DUE TO PACE IMPEDANCE MEASUREMENTS OF GREATER THAN 2,000 OHMS. A NEW DEVICE AND RV LEAD WERE IMPLANTED AND REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14069058 ↗
• MalfunctionApr 6, 2022Failure to Capture; High impedance; Failure to Capture; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD HAD TRIGGERED A RED ALERT DUE TO HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. IN ADDITION, THERE WAS RV LOSS OF CAPTURE (LOC). THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14032498 ↗
• MalfunctionMar 5, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RETURNED FROM OUR FINAL PACK AREA FOR ANALYSIS AS THE PRODUCT HAD NOT PASSED ALL REQUIRED TESTING. THIS ICD WAS NOT IMPLANTED, AND NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13677557 ↗
• InjuryAug 5, 2021High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE PATIENT WAS REFERRED TO THE PHYSICIAN. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285532 ↗
• InjuryMay 5, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE WAS EXPLANTED AT A SURGICAL INTERVENTION DUE TO UNKNOWN PRODUCT PERFORMANCE ISSUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11774870 ↗
• MalfunctionApr 13, 2021Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD EXHIBITED FLUCTUATING PACE IMPEDANCE MEASUREMENTS INCLUDING GREATER THAN 3,000 OHMS. THERE WAS OCCASIONAL NOISE ON THE SHOCK CHANNEL HOWEVER, NO OVERSENSING OBSERVED. SHOCK IMPEDANCE MEASUREMENTS WERE NOTED TO BE STABLE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISOMETRICS AND IMPEDANCES WERE CHECKED IN THE CLINIC AND THERE WAS NO NOISE OR OUT OF RANGE MEASUREMENTS RE-PRODUCED. THE HEALTHCARE PROVIDER WAS GOING TO CONTINUE TO MONITOR THE PATIENT. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11661417 ↗
• InjuryOct 12, 2020Premature Discharge of Battery; Delayed Charge Time; Premature Discharge of Battery; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. IT WAS NOTED THAT THE CHARGE TIME OF 23.0 SECONDS TRIGGERED END OF LIFE (EOL). THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 10668018 ↗
• InjuryApr 30, 2020High impedance; High impedance

  THIS SUPPLEMENTAL REPORT IS BEING FILED AS THE CONCLUSION CODE WAS UPDATED.

  Patient problems: No Code Available

  MAUDE report 10013807 ↗
• InjuryApr 15, 2020Adverse 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 AND EROSION WITH SEPSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 9965663 ↗

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-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-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