DYNAGEN™ MINI ICD DR D022Recalls & reported problems

Summary

The FDA's MAUDE database contains 296 adverse event reports that list this exact device (DI 00802526533907), received between Apr 25, 2016 and Sep 16, 2026 — classified as 1 death, 217 injuries, 78 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (50 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 296 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50796269 ↗
• MalfunctionSep 4, 2026Pacing Problem; Under-Sensing

  It was reported that this implantable cardioverter defibrillator (ICD) stored a ventricular episode where inappropriate anti-tachycardia pacing (ATP) was delivered due to supraventricular tachycardia (SVT). 1:1 condition and ventricular sense beat (VS) were blanking out the atrial sense beat (AS), which led to the delivery of therapy due to V>A. Technical Services (TS) discussed troubleshooting options and programming considerations, and recommended turning off atrial tachy discriminators with RhythmID. This ICD remains in service. No adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600918 ↗
• InjuryAug 20, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that this implantable cardioverter defibrillator (ICD) delivered potential inappropriate therapy for an atrial arrythmia. inappropriate ATP and shock therapy. Technical Services (TS) reviewed the available device data and determined that the episodes were consistent with atrial fibrillation (AF) with rapid ventricular response (RVR). Two episodes resulted in a total of two anti-tachycardia pacing (ATP) bursts and four electric shocks delivered. Reprogramming options were provided and the physician planned to initiate amiodarone therapy. No additional adverse patient effects were reported. This ICD remains in service.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50358902 ↗
• InjuryAug 12, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the health care professional (HCP) requested a review of reports for this implantable cardioverter defibrillator (ICD). Technical Services (TS) reviewed the data and noted the rhythm appeared to be supraventricular tachycardia (SVT) or 1:1 conduction. TS also noted multiple anti-tachycardia pacing (ATP) and shocks were delivered for the suspected 1:1 rhythm. It was also reported the patient experienced palpitations. No additional adverse patient effects were reported. This ICD remains in service.

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

  MAUDE report 50228421 ↗
• MalfunctionJul 14, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED USING A COMMUNICATOR. TECHNICAL SERVICES (TS) WAS CONSULTED AND TROUBLESHOOTING WAS PERFORMED BUT IT WAS UNSUCCESSFUL. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25815460 ↗
• MalfunctionJun 23, 2026Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A CODE 1007 DUE TO CAPACITOR CHARGE TIME EXCEEDING LIMITATIONS. TECHNICAL SERVICES (TS) CONFIRMED THAT THE CHARGE TIME WAS GREATER THAN 45 SECONDS. TS NOTED THE PATIENT DENIED RECEIVING A SHOCK AND RECOMMENDED REPLACING THE ICD AND EVALUATING THE LEAD FURTHER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25595533 ↗
• InjuryJun 12, 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 ALLERGIC REACTION AND POSSIBLE INFECTION. REPORTEDLY, THE PATIENT HAD A DISCHARGE SEEN ON THE IMPLANT SITE DURING THE ROUTINE CLINIC FOLLOW-UP. FURTHERMORE, THE PATIENT WAS SENT FOR AN ALLERGY TEST. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Hypersensitivity/Allergic reaction; Purulent Discharge; Unspecified Infection

  MAUDE report 25484189 ↗
• MalfunctionMay 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) STATED THE DEVICE WAS NOT FUNCTIONING AND HAD NEVER BEEN SET UP, DESCRIBING THE DEVICE AS OPERATING ONLY AS A DEFIBRILLATOR. THE PATIENT ADDED THAT THERE HAD BEEN AN EXPECTATION THAT THE DEVICE WOULD HELP MANAGE ATRIAL FIBRILLATION, WHICH WAS NOT THE CASE. TECHNICAL SERVICES (TS) REFERRED THE PATIENT TO A PHYSICIAN FOR FURTHER EVALUATION. TO DATE, THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247443 ↗
• InjuryMay 14, 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 25176412 ↗
• MalfunctionMar 20, 2026Over-Sensing

  IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO REVIEW THE DATA ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). TECHNICAL SERVICES (TS) THE STORED EPISODES AND NOTED FARFIELD OVERSENSING. TS PROVIDED REPROGRAMMING OPTIMIZATION OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24651535 ↗
• InjuryFeb 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PROVIDED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND DELIVERED TWO INAPPROPRIATE SHOCKS FOR THE PATIENT'S ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR). THE THERAPY CONVERTED THE RHYTHM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24445033 ↗
• MalfunctionFeb 20, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. AT THIS TIME, A SUCCESSFUL INTERROGATION HAS NOT BEEN CONFIRMED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24403328 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A FLUCTUATION PULSE RATE AT ONE FORTY BEATS PER MINUTE WHICH CAUSED THE PATIENT TO WAKE UP. IN ADDITION, THE PATIENT EXPERIENCED PAIN IN THE AREA OF IMPLANT AND EPISODE OF SHOCK THERAPY. THE BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT REFERRED THE PATIENT TO THE PHYSICIAN. 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 A DIFFERENT MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Implant Pain

  MAUDE report 24258060 ↗
• InjuryFeb 3, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A SYNCOPE EPISODE. TECHNICAL SERVICES (TS) REVIEWED AND FOUND CORRELATED STORED EPISODES WITH ANTI-TACHYCARDIA PACING (ATP) INAPPROPRIATELY DELIVERED DUE TO AN ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR). NO SHOCKS WERE DELIVERED. ATP THERAPY CONVERTED THE RHYTHM. THIS DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 24245890 ↗
• MalfunctionJan 28, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1005 INDICATIVE OF AN OPEN CIRCUIT CONDITION DURING SHOCK DELIVERY ON THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE FURTHER TROUBLESHOOTING WAS PLANNED. THE RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203039 ↗
• InjuryJan 21, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POTENTIALLY DELIVERED INAPPROPRIATE THERAPY FOR AN ATRIAL ARRYTHMIA. TECHNICAL SERVICES (TS) REVIEWED THE STORED EPISODES AND DETERMINED THAT THIS DEVICE DELIVERED SIX ANTI-TACHYCARDIA PACING (ATP) BURSTS AND FIVE SHOCKS FOR AN ATRIAL ARRYTHMIA 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 24134245 ↗
• InjuryDec 4, 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. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT HAD A SYSTEMIC INFECTION. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD WAS EXPLANTED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 23714983 ↗
• InjuryNov 13, 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 23546994 ↗
• MalfunctionOct 24, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED RIGHT ATRIAL (RA) CHANNEL FARFIELD OVERSENSING, LEADING TO INAPPROPRIATE ATRIAL TACHY RESPONSE (ATR) EPISODES. TECHNICAL SERVICES (TS) WAS CONSULTED AND RECOMMENDED PROGRAMMING OPTIMIZATION. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23383756 ↗
• InjuryOct 17, 2025Device Difficult to Program or Calibrate; Inappropriate/Inadequate Shock/Stimulation; Interrogation Problem; Device Difficult to Program or Calibrate; Inappropriate/Inadequate Shock/Stimulation; Interrogation Problem

  IT WAS REPORTED THAT THIS INTERROGATION OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNSUCCESSFUL DUE TO LIMITED BATTERY CAPACITY, AS THE ICD HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) IN (B)(6) 2025. IT WAS NOTED THAT THE PATIENT HAD SEVERAL STORED EPISODES WHERE TACHY SHOCKS WERE DELIVERED, AND ONE INSTANCE WHERE THERE WAS KNOWN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND REPLACED FOR ELECTIVE REPLACEMENT TIME (ERT), AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS CONFIRMED THAT INAPPROPRIATE SHOCKS HAD BEEN DELIVERED DUE TO AF WITH RVR PRIOR TO DEVICE CHANGEOUT. THIS WAS ALSO ATTRIBUTED TO A SINGLE THERAPY ZONE DUE TO THE BATTERY BEING AT END OF LIFE (EOL). THE PATIENT REPORTEDLY FELT FINE BEFORE THE SHOCKS, BUT IT WAS ALSO NOTED THAT SHE HAD BEEN EXERTING HERSELF. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23329625 ↗
• InjuryOct 16, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SEVERAL INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SOME INAPPROPRIATE ELECTRIC SHOCK DUE TO POSSIBLE SUPRAVENTRICULAR TACHYCARDIA (SVT). PROGRAMMING OPTIONS WERE DISCUSSED AND RECOMMENDED. CURRENTLY, THIS ICD REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23313946 ↗
• MalfunctionSep 17, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POTENTIALLY DELIVERED INAPPROPRIATE THERAPY. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND CONFIRMED ONE INAPPROPRIATE SHOCK AND THREE ANTI-TACHYCARDIA PACING (ATP) BURSTS WERE DELIVERED DURING AN ATRIAL FIBRILLATION (AF) EPISODE WITH RAPID VENTRICULAR RESPONSE (RVR). THE DEVICE DETERMINED THE VENTRICULAR RATE AS GREATER THAN THE ATRIAL RATE, RESULTING IN SHOCK THERAPY. TS PROVIDED REPROGRAMMING RECOMMENDATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23080055 ↗
• MalfunctionSep 11, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED UNDERSENSING FOR THE PATIENT'S P WAVE ON ITS ATRIAL CHANNEL. 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 23026854 ↗
• InjuryAug 20, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND FOUR SHOCKS FOR WHAT APPEARS TO BE AN ATRIAL DRIVEN RHYTHM. TECHNICAL SERVICES (TS) WAS CONSULTED, AND PROGRAMMING ENHANCEMENTS WERE DISCUSSED AS WELL AS FURTHER ELECTROPHYSIOLOGY REVIEW. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22850614 ↗
• InjuryAug 18, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED TWO SHOCKS FOR AN UNKNOWN REASON. THE DEVICE WAS FOUND TO BE AT END OF LIFE (EOL) AND WAS SUBSEQUENTLY REPLACED FOR NORMAL BATTERY DEPLETION. THIS ICD HAS NOT BEEN RECEIVED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22828318 ↗

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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• 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-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