ORIGEN™ MINI ICD DR D002Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00802526533747), received between Apr 13, 2019 and Apr 13, 2023 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2023Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY AFTER REACHING END OF LIFE (EOL). THIS PATIENT WAS HOSPITALIZED, AND THIS ICD WAS SUCCESSFULLY REPLACED. A REQUEST WAS THEN MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS FOUND THIS PACEMAKER TO HAVE NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE WAS EVENTUALLY RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740508 ↗
• InjuryDec 12, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. THIS DEVICE WAS SUCCESSFULLY REPLACED AND IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960164 ↗
• MalfunctionSep 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. AS A RESULT, DEVICE REPLACEMENT WITHIN 90 DAYS OR MORE FREQUENT MONITORING WAS RECOMMENDED. THIS ICD REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417124 ↗
• InjuryFeb 3, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. 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. THIS DEVICE WAS REPLACED AND IS EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444779 ↗
• InjuryOct 15, 2021Material Integrity Problem; High Capture Threshold; Material Integrity Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH PACING THRESHOLDS. IT WAS OBSERVED THAT BLOOD WAS PRESENT IN THE RV CHANNEL OF THE ICD HEADER AND THE ICD WAS EXPLANTED AND REPLACED WITHOUT COMPLICATION. THE ICD WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643303 ↗
• InjuryOct 12, 2021Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE SYNCOPE AND PACING INHIBITION WAS NOTED. THE PATIENT WAS HOSPITALIZED. REVIEW OF THE DATA WAS REQUESTED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN SERVICE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAM (EGM) STRIP AND NOTED OVERSENSING OF A FAR-FIELD SIGNAL OF THE ATRIAL PACE CAUSING PACING INHIBITION. TS NOTED THAT THE OVERSENSING COULD NOT BE RULED OUT AS A POTENTIAL CAUSE OF THE PATIENT'S SYNCOPE. TS FURTHER DISCUSSED TROUBLESHOOTING AND PROGRAMMING OPTIONS. THE CLINIC REPROGRAMMED THE ICD. THE ICD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting

  MAUDE report 12618668 ↗
• MalfunctionJan 26, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPORTED TO HAVE BEEN PHYSICALLY DAMAGED AND HAD 'CRACKED' ACCORDING TO A PATIENT ADVOCATE. THE PATIENT WAS ADVISED TO CONTACT THEIR DOCTOR AND THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11233757 ↗
• InjuryJul 29, 2020Premature Discharge of Battery; Battery Problem; Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED END OF LIFE (EOL) AND WAS IN SAFETY MODE FOLLOWING ABDOMINAL SURGERY FOR THIS PATIENT. DURING A PREVIOUS FOLLOW UP IN NOVEMBER 2019, THE DEVICE DISPLAYED NORMAL BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE HAS BEEN RETURNED AND ANALYSIS HAS BEEN COMPLETED. THIS REPORT HAS BEEN UPDATED WITH THE PRODUCT INVESTIGATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 10340876 ↗
• MalfunctionAug 8, 2019High impedance; Noise, Audible; High impedance; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEEPING DUE TO A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS ON THE RIGHT ATRIAL CHANNEL. NO CHANGES HAVE BEEN MADE AND THE ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8876082 ↗
• InjuryJul 31, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE BATTERY HAD ALLEGEDLY PREMATURELY DEPLETED. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8847173 ↗
• MalfunctionApr 26, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE REACHED A STATUS OF PREMATURE BATTERY DEPLETION, INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY, PRIOR TO IMPLANT. THE DEVICE WAS NOT IMPLANTED. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED.

  Patient problems: No Patient Involvement

  MAUDE report 8557706 ↗
• MalfunctionApr 13, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEHAVING IN A MANNER CONSISTENT WITH A RECORDED CODE 1003 INDICATIVE OF PREMATURE BATTERY DEPLETION AND TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) PRE-IMPLANT. NO PATIENT INVOLVEMENT. AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

  Patient problems: No Patient Involvement

  MAUDE report 8512380 ↗

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-1513-2008 · Jan 7, 2008 · Terminated
  VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872
• Z-1514-2008 · Jan 7, 2008 · Terminated
  VITALITY EL, models T127, T167, T177 Implantable Cardioverter Defibrillator (ICD), pulse-generator, dual Chamber
• 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-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-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