DYNAGEN MINI ICD DRRecalls & reported problems across all models

We found 2 models of DYNAGEN MINI ICD DR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 373 adverse event reports in the FDA's MAUDE database, received between Apr 25, 2016 and Sep 16, 2026 — classified as 1 death, 260 injuries, 112 malfunctions.

The most frequently reported specific device problem is “High impedance” (76 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DYNAGEN MINI ICD DR problems

DYNAGEN MINI ICD DR models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DYNAGEN™ MINI ICD DR D022

  Implantable cardioverter defibrillator (non-CRT)
  1 death296 reports
• DYNAGEN™ MINI ICD DR D023

  Implantable cardioverter defibrillator (non-CRT)
  77 reports

Recent DYNAGEN MINI ICD DR adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryApr 23, 2026Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR STATE RESULTING TO DEVICE DATA UPLOAD ANOMALY. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THAT THE DEVICE BATTERY COULD GO TO END OF LIFE BATTERY STATE AT ANY TIME AND DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, TACHY THERAPY WAS PROGRAMMED OFF. THE TS CONSULTANT DISCUSSED THAT IF THE PACING MODE IS CURRENTLY DEACTIVATED, THIS THERAPY CANNOT BE REACTIVATED AFTER THE BATTERY CAPACITY IS DEPLETED, THOUGH THIS MAY BE TURNED OFF LATER IF THIS REMAINS IN A SENSING-ONLY MODE. 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 24968282 ↗
• 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 ↗

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