ORIGEN™ CRT-D G051Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00802526534478), received between Oct 25, 2018 and Dec 8, 2022 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High impedance” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem; Interrogation Problem; Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem; Interrogation Problem

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED WITH THE 3300 PROGRAMMER NOR WITH THE 3120 PROGRAMMER. THERE WERE NO BEEPS TONES WITH THE MAGNET AND THE PACING RATE WERE AT 60 BPM. ADDITIONALLY, THE DEVICE WAS SUSPECTED OF PREMATURE BATTERY DEPLETION. THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15940942 ↗
• MalfunctionOct 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE EXHIBITED CODE 1003 INDICATIVE OF BATTERY VOLTAGE WAS TOO LOW FOR THE PROJECTED REMAINING CAPACITY. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED AND RECOMMENDED THAT THE DEVICE SHOULD BE REPLACED WITHIN 28 DAYS. AT THIS TIME, THE DEVICE REMAINS IMPLANTED AND IN-SERVICE. THE PATIENT WAS STABLE WITH NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633143 ↗
• InjuryNov 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FOUND TO BE OPERATING IN SAFETY MODE, INDICATING THE DEVICE WAS PROVIDING LIMITED THERAPY AND WAS NON-PROGRAMMABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS HOSPITALIZED FOR IMMEDIATE DEVICE REPLACEMENT; HOWEVER, THE PROCEDURE WAS SUBSEQUENTLY RESCHEDULED AND WAS PERFORMED 10 DAYS LATER. THE EXPLANTED DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756391 ↗
• InjuryJul 2, 2021Inappropriate/Inadequate Shock/Stimulation; Inaccurate Synchronization; Inappropriate/Inadequate Shock/Stimulation; Inaccurate Synchronization

  IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER MULTIPLE SHOCK DELIVERIES. DEVICE INTERROGATION OF THE EVENT REVEALED REPEATED ATRIAL PACING THAT INDUCED A VENTRICULAR ARRHYTHMIA. DIAGNOSTIC IMAGING WAS PERFORMED AND NO ABNORMALITIES WERE NOTED IN THIS SYSTEM. THE DEVICE DATA WAS FORWARDED TO BOSTON SCIENTIFIC TECHNICAL SERVICES AND THE INAPPROPRIATE ATRIAL PACING WAS DISCUSSED. IT WAS STATED THAT THE PHYSICIAN WAS ABLE TO REPROGRAM THE ATRIAL-VENTRICULAR SENSING DELAY TO RESOLVE THE EVENT. IT IS UNKNOWN IF THE PATIENT'S LEFT VENTRICULAR ASSISTANCE DEVICE (LVAD) WAS INVOLVED IN THIS EVENT. THE PATIENT WAS STABLE AND THE SYSTEM REMAINS IMPLANTED AND IN-SERVICE.

  Patient problems: Arrhythmia; Electric Shock

  MAUDE report 12112248 ↗
• InjuryApr 15, 2021Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNDERSENSING AND INHIBITION OF PACING. THIS PATIENT IS PACEMAKER-DEPENDENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THIS CRT-D REMAINS IN SERVICE. ADDITIONAL INFORMATION RECEIVED INDICATES THIS CRT-D WAS EXPLANTED AND REPLACED, AND A NEW RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. PER THE LOCAL AREA FIELD REPRESENTATIVE, THE EXPLANTED CRT-D WAS DISCARDED BY THE CUSTOMER AND THEREFORE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11669326 ↗
• MalfunctionOct 20, 2020High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm; High impedance; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Convert Rhythm

  THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND UNKNOWN MODEL RIGHT VENTRICULAR (RV) LEAD DECLARED FC1005 (SHOCK TO OPEN CONDUCTION) FROM AN OUT-OF-RANGE SHOCK LEAD IMPEDANCE GREATER THAN 145OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES REVIEWED THE AVAILABLE DATA AS INITIALLY THE PHYSICIAN REQUESTED INSIGHT TO SHOCK THERAPY FOR THE VENTRICULAR TACHYCARDIA (VT) EPISODES. IT WAS CONFIRMED THAT THE MOST RECENT SHOCK THERAPY DELIVERED WAS WITHIN NORMAL SHOCK IMPEDANCE RANGE. ADDITIONALLY, THE BIV TRIGGERED PACE CANNOT BE EXCLUDE FROM CONTRIBUTING TO ANY OF THE GIVEN ARRHYTHMIAS, HOWEVER THE BIV TRIGGER MIGHT ALSO HAVE BEEN TRIGGERED BY AN ARRHYTHMIC VENTRICULAR EVENT. IT IS SUSPECTED THE LEAD SYSTEM IS DAMAGED OR DISCONNECTED. THE PHYSICIAN HAS REPROGRAMMED THE DEVICE. THE DEVICE REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Tachycardia

  MAUDE report 10707912 ↗
• MalfunctionFeb 4, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD AN ESTIMATED LONGEVITY OF 1.5 YEARS REMAINING HAVING ONLY BEEN IMPLANTED 30 DAYS. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS SHOWED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. DEVICE REPLACEMENT WAS RECOMMENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9666447 ↗
• InjuryJan 24, 2020High impedance; Device Displays Incorrect Message; High impedance; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS IMPLANTED SYSTEM EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS. DEFIBRILLATION THRESHOLD TESTING WAS PERFORMED AND A SHOCK FAILED AND CODE 1005 WAS EXHIBITED BY THE DEVICE. SURGICAL INTERVENTION WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND THE RIGHT VENTRICULAR LEAD WAS ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9628854 ↗
• MalfunctionOct 25, 2018High impedance; High impedance

  IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED MULTIPLE HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2000 OHMS ON THE RIGHT VENTRICULAR (RV) CHANNEL. THE RV LEAD IS A NON-BOSTON SCIENTIFIC PRODUCT. NO CHANGES WERE MADE TO THE SYSTEM AND THE CRT-D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8006202 ↗

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-0081-2018 · Oct 4, 2017 · Terminated
  RESONATE X4 CRT-D, Model G447, Sterile.
• Z-0080-2018 · Oct 4, 2017 · Terminated
  MOMENTUM X4 CRT-D, Model G138, 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-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-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-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-0826-06 · Apr 7, 2006 · Terminated
  Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Ha

…and 4 more.