DYNAGEN MINI ICD VRRecalls & reported problems across all models

We found 2 models of DYNAGEN MINI ICD VR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 232 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2016 and Sep 8, 2026 — classified as 1 death, 166 injuries, 65 malfunctions.

The most frequently reported specific device problem is “High impedance” (41 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 VR problems

DYNAGEN MINI ICD VR models

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

• DYNAGEN™ MINI ICD VR D020

  Implantable cardioverter defibrillator (non-CRT)
  1 death188 reports
• DYNAGEN™ MINI ICD VR D021

  Implantable cardioverter defibrillator (non-CRT)
  44 reports

Recent DYNAGEN MINI ICD VR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Premature Discharge of Battery

  It was reported that the implantable cardioverter defibrillator (ICD) was interrogated and observed that it reached battery capacity depleted and recorded a Code 1003 indicative of battery voltage too low for the projected remaining capacity. Subsequently, this device was explanted and replaced. No additional adverse patient effects were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50660120 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A POSSIBLE POCKET EROSION DUE TO FALL, AND A SWELLING NOTED AT THE IMPLANT SITE. THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD REMAINED IN SERVICE.

  Patient problems: Pocket Erosion; Swelling/ Edema

  MAUDE report 25827421 ↗
• InjuryJun 29, 2026Defibrillation/Stimulation Problem; Failure to Read Input Signal; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONTACTED EMERGENCY MEDICAL SERVICES (EMS) DUE TO NOT FEELING WELL. THE PATIENT SUBSEQUENTLY LOST CONSCIOUSNESS WHILE PULLING INTO THE EMERGENCY ROOM (ER) AND SPEAKING WITH PARAMEDICS AND DID NOT REGAIN CONSCIOUSNESS. THE PATIENT WAS TRANSPORTED TO A MEDICAL FACILITY WHERE DEVICE INTERROGATION WAS PERFORMED. THE INTERROGATION REVEALED THIS ICD EXHIBITED UNDERSENSING OF VENTRICULAR FIBRILLATION (VF). TECHNICAL SERVICES (TS) REVIEWED THE DATA AND DETERMINED THE INITIAL EPISODE CONSISTED OF FINE VF WITH SIGNAL AMPLITUDES BELOW THE PROGRAMMED RATE CUT OFF. INTERMITTENT TALL-SHORT CONTRIBUTED TO THE UNDERSENSING, WHICH RESULTED IN INAPPROPRIATE DETECTION WITHIN THE VENTRICULAR TACHYCARDIA (VT) ZONE. DURING THE SUBSEQUENT EPISODE, THE DEVICE DETECTED TACHYARRHYTHMIA BUT DID NOT CONSISTENTLY DELIVER THERAPY. DEVICE LOGS DOCUMENTED THAT NO THERAPY WAS DELIVERED FOR MULTIPLE THERAPY ATTEMPTS, WITH ONLY ONE ANTI-TACHYCARDIA PACING (ATP) AND ONE SHOCK DELIVERED, DESPITE THE CONTINUED ARRHYTHMIA. THERAPY ATTEMPTS WERE EXHAUSTED WHILE THE ARRHYTHMIA PERSISTED. IT WAS SUSPECTED, BUT NOT CONFIRMED, THAT A MAGN

  Patient problems: Malaise; Syncope/Fainting

  MAUDE report 25659557 ↗
• MalfunctionJun 24, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DUE TO MYOPOTENTIAL OVERSENSING ON THE SHOCK CHANNEL. TECHNICAL SERVICES (TS) REVIEWED AND PROVIDED REPROGRAMING OPTIONS. THIS ICD AND RV LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612028 ↗
• InjuryJun 22, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE FIELD REPRESENTATIVE WAS CONTACTED BY CLINICIAN TO CHECK THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DATA DUE TO REPORTS OF SHOCKS. THE FIELD REPRESENTATIVE STATED THAT UPON INTERROGATION, THE DEVICE BATTERY CAPACITY WAS FOUND TO HAVE DEPLETED AND WAS NOT ABLE TO REVIEW ANY EPISODES. IT WAS NOTED PLANS FOR GENERATOR REPLACEMENT PROCEDURES WERE IN PROGRESS AND THE PATIENT WAS INCLINED TO EXPLANT THE DEVICE. SUBSEQUENTLY, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THIS ICD WAS EXPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25588740 ↗
• MalfunctionJun 3, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Failure to Read Input Signal

  IT WAS REPORTED THAT ELECTROGRAM (EGM) REVIEW WAS REQUESTED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WITH HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS ON THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED, AND RV RATE SENSING HAD DROPPED SIGNIFICANTLY WITH PACE IMPEDANCE MEASUREMENTS DECREASING FROM 400 OHMS TO LESS THAN 200 OHMS. THERE WERE NUMEROUS VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) EPISODES CONTAINING NON-PHYSIOLOGIC NOISE ON THE RV RATE SENSE AND SHOCK EGMS. TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS, RECOMMENDED AN IN-OFFICE CHECK TO EVALUATE RV LEAD INTEGRITY. THIS ICD SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Shock from Patient Lead(s)

  MAUDE report 25383162 ↗
• MalfunctionApr 15, 2026High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS FOUND TO BE EXHIBITING FAULT CODE 1005 PRIOR TO HIP SURGERY. TECHNICAL SERVICES (TS) RECOMMENDED SYSTEM REPLACEMENT. THIS ICD REMAINS IN SERVICE. THE PATIENT IS LOST TO FOLLOW UP, SO NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886945 ↗
• InjuryFeb 27, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 ON INTERROGATION. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468871 ↗
• InjuryFeb 26, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SIX ANTI-TACHYCARDIA PACING (ATP) THAT ACCELERATED THE HEART RHYTHM; LATER ON, THREE ROUNDS OF SHOCKS WERE DELIVERED WHICH CONVERTED THE RHYTHM. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24456773 ↗
• InjuryFeb 25, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE EXHIBITING PREMATURE BATTERY DEPLETION. DIFFERING REMAINING LONGEVITY ESTIMATES HAD BEEN DISPLAYED BY THE DEVICE OVER THE PRIOR YEAR. REMOTE MONITORING WAS DISABLED. ANALYSIS OF STORED DEVICE DATA WAS UNABLE TO BE COMPLETED DUE TO LIMITED AVAILABLE DATA. DEVICE REPLACEMENT WAS RECOMMENDED. SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD HAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445060 ↗
• InjuryFeb 16, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY AND SHOCKS WERE DELIVERED DUE TO ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE (RVR). TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THAT THE DEVICE OPERATED AS PROGRAMMED THEREFORE RECOMMENDED REPROGRAMMING ENHANCEMENTS. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24345658 ↗
• InjuryJan 26, 2026Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1007, WHICH STATES THAT THE CAPACITOR CHARGE TIME HAS EXCEEDED THE LIMIT. IN ADDITION, THE DEVICE EXHIBITED AN ALERT INDICATING THAT EXPLANT INDICATOR HAD BEEN REACHED AND THEREFORE THE REMOTE MONITORING WAS DISABLED. THIS ICD WAS SUCCESSFULLY EXPLANTED AND HAS NOT BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184307 ↗
• MalfunctionJan 21, 2026Interrogation Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNABLE TO BE INTERROGATED. THE HEALTH CARE PROFESSIONAL (HCP) CONFIRMED THEY WERE USING THE PROGRAMMER AND THE CORRECT WAND. THE DEVICE WAS UNABLE TO BE IDENTIFIED. TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING AND THE ISSUE PERSISTED. THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130748 ↗
• MalfunctionDec 22, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A SYNCOPAL EPISODE AND DISCOMFORT. THE ICD WAS SUSPECTED OF DELIVERING AN INAPPROPRIATE SHOCK; HOWEVER, THE SUSPECTED EPISODE COULD NOT BE VIEWED DUE TO A BATTERY CAPACITY DEPLETED (BCD) ALERT. TECHNICAL SERVICES (TS) RECOMMENDED REPLACING THE DEVICE. SUBSEQUENTLY, THIS ICD WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, AND THIS ICD HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Shock from Patient Lead(s); Syncope/Fainting

  MAUDE report 23864807 ↗
• InjuryNov 27, 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 THE POSSIBLE INFECTION AND FLUID DISCHARGE ISSUE. REPORTEDLY, THE PATIENT HAD WATER SAC UNDER THE ARM, AND THE ICD HAD BEEN LEAKING. THE PHYSICIAN INFORMED THAT THE PATIENT MAY HAVE A BACTERIAL INFECTION. THE PATIENT ADDED THAT THE WATER SAC HAD BEEN THERE FOR SEVERAL MONTHS. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INFORMED THAT THE ICD WAS NOT ON ANY ADVISORIES AND DOES NOT LEAK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD REMAINS IMPLANTED. ADDITIONAL INFORMATION INDICATED THAT THE ICD WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23669049 ↗

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