ORIGEN™ CRT-D G050Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00802526534454), received between Apr 17, 2020 and Feb 28, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (2 reports).

19 other recalls cover devices cleared under the same FDA submission (P010012); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LOSS OF CAPTURE DURING A HIGH-RATE PACING DURING TAVI DELIVERY. THE PHYSICIAN DECIDED TO IMPLANT A TEMPORARY PACEMAKER LEAD INTO THE RIGHT VENTRICULAR (RV) BECAUSE 180PPM WERE REQUIRED FOR TAVI DELIVERY. WHEN STIMULATING AT 180PPM WITH THE TEMPORARY LEAD, EVERY STIMULUS WAS CAPTURING THE VENTRICLE. THE RV AND LEFT VENTRICULAR (LV) PACING CAPTURE THRESHOLD WERE WITHIN NORMAL RANGE. THE PHYSICIAN IS NOW WORRIED THAT RV/LV CAPTURE DURING ATP DELIVERY MIGHT BE AS UNSUCCESSFUL AS DURING THIS HIGH-RATE PACING ATTEMPT AND HAD REQUESTED ADVICE. DATA HAS BEEN PROVIDED FOR REVIEW, BOSTON SCIENTIFIC TECHNICAL SERVICES CONFIRMED LOSS OF CAPTURE ON FAST-RATE PACING, HOWEVER THERE WAS CAPTURE OBSERVED ON THE ATP DELIVERY AND THE DEVICE WAS ABLE TO CAPTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN-SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457128 ↗
• InjuryJan 30, 2023Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE BATTERY OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUSPECTED TO BE PREMATURELY DEPLETING. THE CRT-D WAS ALSO IN SAFETY MODE. SURGICAL INTERVENTION WAS PERFORMED AND THE CRT-D WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D 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 16265933 ↗
• InjuryOct 12, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE WAS EXPLANTED WITH SUSPECTED PREMATURE BATTERY DEPLETION HOWEVER IT WAS KNOWN/REPORTED THAT THE LEFT VENTRICULAR LEAD HAD BEEN PROGRAMMED WITH HIGH OUTPUTS. THE EXPLANTED UNIT IS EXPECTED TO BE RETURNED FOR ANALYSIS AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10667693 ↗
• MalfunctionApr 17, 2020High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH RIGHT ATRIAL COMPETITOR LEAD DISPLAYED PACING LEAD IMPEDANCES GREATER THAN 3000 OHMS. THE SENSING AND THRESHOLD MEASUREMENTS REMAINED STABLE DURING POCKET MANIPULATION TESTING AND NO ARTIFACTS WERE SEEN. THE PHYSICIAN ELECTED TO REPROGRAM THE CRT-D FROM VDD TO DDD AND TO FOLLOW UP WITH PATIENT IN THREE MONTH INTERVALS. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9972924 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010012. One submission often covers many models, so check the product and lot details in each record.

• Z-1671-2022 · 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-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, Sterile.
• Z-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-1556-2010 · Mar 15, 2010 · Terminated
  Boston Scientific LIVIAN Cardiac Resynchronization Therapy Defibrillator (CRT-D), models H220, H225, H227, H229. The LIVIAN family of cardiac resynchronization therapy defibrillat
• Z-0609-2010 · Dec 1, 2009 · Terminated
  Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107,
• Z-1054-2007 · Mar 23, 2007 · Terminated
  VITALITY DR HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 U
• Z-1049-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 RF (model H210, H215), CONTAK RENEWAL 3 RF HE (model H217, H219) cardiac resynchronization therapy defibrillator (CRT-D).
• Z-1055-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 EL DR/VR (model T167, T177). contents have been sterilized with gaseous ethylene oxide. The Guidant Vitality 2 ICD, implantable cardioverter defibrillators, are design
• Z-1047-2007 · Mar 23, 2007 · Terminated
  CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North,
• Z-1052-2007 · Mar 23, 2007 · Terminated
  VITALITY AVT (model A155). Implantable Cardioverter Defibrillator. Atrial and Ventricular Therapies. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. P
• Z-1053-2007 · Mar 23, 2007 · Terminated
  VITALITY 2 (model T165, T175), VITALITY DS (model T125, T135), VITALITY EL (model T127), Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventric
• Z-0047-2008 · Mar 16, 2007 · Terminated
  Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.
• Z-1288-06 · May 15, 2006 · Terminated
  Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Ave
• Z-0827-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55

…and 4 more.