ORIGEN™ MINI ICD DR D003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00802526533761), received between Jan 21, 2020 and Apr 9, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO HAVE PREMATURELY DEPLETED. SURGICAL INTERVENTION WAS PERFORMED AND THE S-ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD IS EXPECTED TO BE RETURNED BACK FROM THE FIELD FOR ANALYSIS, THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068934 ↗
• InjuryJul 22, 2020Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED AFTER RECEIVING TWO INAPPROPRIATE SHOCKS. NOISE WAS SEEN POST SHOCK DELIVERY. PROVOCATION TESTING WAS PERFORMED WITH NO ABNORMAL MEASUREMENTS. IT WAS ALSO NOTED THAT THE PATIENT HAD REPORTED FEELING DIZZY. AN INQUIRY REGARDING THE CASE WAS SENT FOR REVIEW TO TECHNICAL SERVICES (TS) AS POSSIBLE ELECTROMAGNETIC INTERFERENCE (EMI) WAS SUSPECTED. TS REVIEWED THE EPISODES AND NOTED THAT THE SHOCK ELECTROGRAM WAS POINTING TOWARDS A FAST VENTRICULAR RHYTHM. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dizziness; Electric Shock

  MAUDE report 10311274 ↗
• InjuryJul 9, 2020High impedance; High impedance

  IT WAS REPORTED THAT AN INQUIRY REGARDING HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS WAS REQUESTED WHEN IT COMES TO THIS DEVICE. A REVIEW OF THE REMOTE MONITORING DATA BY TECHNICAL SERVICES (TS) NOTED THAT THE FIRST HIGH RIGHT VENTRICULAR LEAD MEASUREMENTS STARTED (B)(6) 2018. IT WAS NOTED THAT THE VALUES WERE GREATER THEN 3,000 OHMS MOST OF LAST YEAR. TS NOTED THAT DUE TO THAT FACT THAT WE LONGER CAN EVALUATE THE LEADS PERFORMANCE A LEAD EVALUATION SHOULD BE CONSIDERED. AT THIS TIME THE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10255412 ↗
• InjuryMay 6, 2020Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation; Premature Discharge of Battery; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD RECEIVED MULTIPLE INAPPROPRIATE SHOCKS WHILE AT HOME. THE PATIENT WAS NOT SYMPTOMATIC PRIOR TO THE SHOCKS. AFTER ABOUT 10 SHOCKS, THE PATIENT WAS TAKEN BY AMBULANCE TO THE NEAREST CLINIC, WHERE THE PHYSICIAN ON DUTY DID NOT PUT A MAGNET OVER THE DEVICE AND DID NOT CONTACT BOSTON SCIENTIFIC FOR ASSISTANCE. THE SHOCKS CONTINUED UNTIL THE BATTERY CAPACITY WAS DEPLETED. THE PATIENT WAS LATER TRANSPORTED TO ANOTHER CLINIC AND A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED. IT WAS NOTED THE LEADS WERE TESTED WITH NORMAL MEASUREMENTS OBSERVED, AND REMAIN IMPLANTED WITH THE NEW DEVICE. IT WAS ALSO REPORTED THAT NO SAVE TO DISK COULD BE PERFORMED AND THE SHOCK EPISODES COULD NOT BE REVIEWED, DUE TO THE DEPLETED BATTERY. THE EXPLANTED DEVICE WAS RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock; No Code Available

  MAUDE report 10027643 ↗
• MalfunctionApr 17, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DELIVERED MULTIPLE INAPPROPRIATE SHOCKS TO THE PATIENT DUE TO SINUS TACHYCARDIA. NO CHANGES WERE MADE AND THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9972861 ↗
• InjuryJan 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message; Incorrect, Inadequate or Imprecise Result or Readings; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED CODE 1005 INDICATIVE SHORTED SHOCK ON THE RIGHT VENTRICULAR (RV) LEAD. INTERVENTION WAS PERFORMED. THE DEVICE WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED.

  Patient problems: No Code Available

  MAUDE report 9611917 ↗

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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, 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-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-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• Z-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• 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