ORIGEN™ MINI ICD VR D001Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00802526533723), received between Jan 22, 2019 and Sep 15, 2022 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “High impedance” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 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 WHEN THE PACEMAKER REACHED THE ELECTIVE REPLACEMENT INDICATOR (ERI). HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLD WERE NOTED, AND UPON REPROGRAMMING THE DEVICE, THE BATTERY IMPROVED WITH ONE YEAR OF BATTERY LONGEVITY REMAINING. TECHNICAL SERVICES (TS) REVIEWED THE CASE, AND REITERATED THAT LONGEVITY IS ACCURATE OVER THE SERVICE LIFE OF THE DEVICE, BUT IS IMPRECISE NEARING EXPLANT/ERI DUE TO UNCERTAINTIES AND SENSITIVITY TO SMALL CHANGES. DISK DATA WAS REQUESTED TO CONFIRM BATTERY LONGEVITY. THIS INVESTIGATION WILL BE UPDATED WHEN FURTHER INFORMATION IS PROVIDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427830 ↗
• MalfunctionMay 28, 2022High impedance; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation; High impedance; Pacing Problem; Incorrect, Inadequate or Imprecise Result or Readings; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM PRESENTED TO THE HOSPITAL DUE TO RECEIVING ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. AT THE TIME OF THE LAST DELIVERED SHOCK THE SHOCK IMPEDANCE WAS NOTED TO HAVE REACHED OUT OF RANGE REACHING GREATER THAN 125 OHMS. ALL OTHER SHOCKS HAD RECORDED IMPEDANCE MEASUREMENTS WITHIN NORMAL LIMITS. DEVICE DATA WAS SENT TO TECHNICAL SERVICES (TS) FOR REVIEW. DEVICE DATA DETERMINED THE DEVICE RECORDED A CODE 1005 ASSOCIATED WITH AN OPEN CIRCUIT AT THE TIME SHOCK WAS DELIVERED. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 14536966 ↗
• MalfunctionApr 16, 2022Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem; Incorrect, Inadequate or Imprecise Result or Readings; Interrogation Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED CODE 1007 INDICATIVE OF CHARGE TIMES EXCEEDING LIMITATIONS AND WAS NOT RESPONDING TO TELEMETRY. THE PHYSICIAN WAS CONSIDERING DEVICE REPLACEMENT. IT WAS STATED THAT THE PATIENT'S HEALTH WAS POSSIBLY TOO CRITICAL TO TOLERATE A REPLACEMENT PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR A DIFFERENT ISSUE, NEEDED DIALYSIS, AND WAS DISABLED TO A CERTAIN EXTENT. ADDITIONAL INFORMATION IS BEING REQUESTED, BUT WAS UNAVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14131864 ↗
• InjuryApr 10, 2022Premature 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 ERROR CODE 1007 AND 1003 WERE DISPLAYED SINCE THE LAST DEVICE FOLLOW UP. A REVIEW OF THE DEVICE DATA BY TECHNICAL SERVICES (TS) NOTED THAT THE SINCE THE DEVICE HAD TRIGGERED END OF LIFE (EOL) THERE WAS LITTLE DIAGNOSTIC DATA . TS CONFIRMED THE ERROR CODES AND NOTED THAT FAULT CODE 1007 INDICATED THAT THE CAPACITOR CHARGE TIME WAS EXCEEDED. THE LAST CAPACITOR REFORM WAS (B)(6) 2021 AND THE CHARGE TIME EXCEEDED 45 SECONDS, AFTER WHICH THE DEVICE ABORTS FURTHER CHARGING. TS ALSO NOTED THAT SINCE THE DEVICE TRIGGERING FC1003 THE BATTERY WAS DEPLETING MORE QUICKLY THAN EXPECTED. IMMEDIATE DEVICE REPLACEMENT WAS RECOMMENDED. THE DEVICE REMAINS IMPLANTED. THE PATIENT REMAINED HOSPITALIZED AND NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14069122 ↗
• MalfunctionNov 2, 2021High impedance; High impedance

  IT WAS REPORTED THAT THE SHOCK IMPEDANCE OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS GREATER THAN 200 OHMS. THE PHYSICIAN WAS INFORMED AND BOTH THE ICD AND RIGHT VENTRICULAR LEAD REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12735608 ↗
• MalfunctionMay 3, 2021Device Alarm System; High impedance; Device Alarm System; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE AND RIGHT VENTRICULAR (RV) LEAD, EXHIBITING HIGH, OUT OF RANGE PACING IMPEDANCE MEASUREMENTS (GREATER THAN 3,000 OHMS) AND AUDIBLE TONES. DURING THE ROUTINE OFFICE VISIT THE PHYSICIAN PERFORMED LEAD INTEGRITY TESTING WITH EXCESSIVE MOVEMENT MANEUVERS, AND THEY COULD NOT REPRODUCE THE OUT OF RANGE MEASUREMENTS OR BEEPING TONES. AN X-RAY WAS PERFORMED, AND THE PHYSICIAN DID NOT SEE ANY ABNORMALITIES. A TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED FOLLOWING THE PATIENT CLOSELY WITH A HOME MONITOR. THE DEVICE REMAINS IMPLANTED. IT WAS NOTED THAT THIS PATIENT ATTENDS BIORESONANCE THERAPY REGULARLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED, THE PATIENT WAS SEEN FOR A FOLLOW UP APPOINTMENT AND THERE WERE NO OUT OF RANGE MEASUREMENTS NOTED. THE PHYSICIAN WILL CONTINUE TO MONITOR THIS PATIENT CLOSELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11767117 ↗
• MalfunctionJan 26, 2021High impedance; High impedance

  IT WAS REPORTED DURING A ROUTINE FOLLOW UP APPOINTMENT, THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEVICE EXHIBITED HIGH, OUT OF RANGE PACING IMPEDANCE (GREATER THAN 3,000 OHMS). IT WAS SUSPECTED THAT THE RIGHT VENTRICULAR LEAD COULD BE FRACTURED. THE DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A TECHNICAL SERVICE (T/S) CONSULTANT REVIEWED THE DEVICE DATA AND RECOMMENDED LEAD INTEGRITY TESTING BY PERFORMING ARM MANEUVERS AND MANIPULATION. T/S ALSO RECOMMENDS FOLLOWING THE PATIENT CLOSELY OVER THE HOME MONITOR EQUIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11232921 ↗
• MalfunctionJul 22, 2020High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 150 OHMS ON THE RIGHT VENTRICULAR (RV) LEAD CHANNEL. A LEAD REVISION PROCEDURE WAS SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE HOSPITAL REGARDING THE EVENT RESOLUTION, BUT NO INFORMATION WAS RECEIVED. AT THIS TIME, THE DEVICE REMAINS IN SERVICE. THERE WAS NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311415 ↗
• MalfunctionJul 2, 2020High impedance; High impedance

  IT WAS REPORTED THAT A HIGH, OUT OF RANGE PACING IMPEDANCE (>3000 OHMS) MEASUREMENT WAS NOTED FROM A COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES WERE CONTACTED AND RECOMMENDED IN-CLINIC MANEUVERS TO ASSESS THE RV LEAD INTEGRITY. PROVOCATIVE MANEUVERS WERE PERFORMED AND NO NOISE WAS SEEN AND THE PACING IMPEDANCE WAS IN RANGE. THE PHYSICIAN ELECTED TO CONTINUE WITH REMOTE MONITORING AND REMOTE FOLLOW UPS. THE SYSTEM REMAINS IMPLANTED AND IN SERVICE. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10226564 ↗
• MalfunctionApr 17, 2020Device Alarm System; High impedance; Device Alarm System; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ICD WITH COMPETITOR RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCES GREATER THAN 3000 OHMS AND PATIENT NOTED THE DEVICE EMITTED TONES. BOSTON SCIENTIFIC TECHNICAL SERVICES REVIEWED THE DATA AND NOTED SLIGHT GRADUAL INCREASE IN PACING LEAD IMPEDANCES BUT WITHIN RANGE SINCE RV LEAD IMPLANT IN (B)(6) 2019 AND STARTED TO SPIKE OUT-OF-RANGE (B)(6) 2019. ALL OTHER MEASUREMENTS ARE STABLE AND THERE ARE NO STORED EPISODES OF NOISE. THE SYSTEM 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 9972870 ↗
• MalfunctionJan 28, 2020High impedance; Device Displays Incorrect Message; High impedance; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS PATIENT'S IMPLANTED SYSTEM HAD DELIVERED A SHOCK WHICH RESULTED IN CODE 1005 BEING EXHIBITED WHICH IS INDICATIVE OF A SHOCK INTO AN OPEN LEAD. A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS WAS ALSO OBSERVED. THE SYSTEM HAS BEEN REPROGRAMMED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9638262 ↗
• InjuryJan 28, 2020Premature Discharge of Battery; Telemetry Discrepancy; Interrogation Problem; Premature Discharge of Battery; Telemetry Discrepancy; Interrogation Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO HAVE PREMATURELY DEPLETED. THE ICD WAS UNABLE TO BE INTERROGATED AS WELL. SURGICAL INTERVENTION WAS PERFORMED AND THE ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9638248 ↗
• InjuryJan 6, 2020Delayed Charge Time; Device Displays Incorrect Message; Delayed Charge Time; Device Displays Incorrect Message

  IT WAS REPORTED THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DECLARED CODE 1007, CAPACITOR CHARGE TIME HAS EXCEEDED THE LIMIT. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO HAVE DEVICE EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. 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 Consequences Or Impact To Patient

  MAUDE report 9549882 ↗
• MalfunctionOct 14, 2019High impedance; Noise, Audible; High impedance; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS BEEPING AS IT HAD EXHIBITED A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT OF GREATER THAN 2000 OHMS. 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 9187602 ↗
• MalfunctionJun 19, 2019High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES ON THE RIGHT VENTRICULAR (RV) CHANNEL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED DATA FROM THE SYSTEM AND PROVIDED TROUBLESHOOTING RECOMMENDATIONS. THE TESTING WILL BE PERFORMED AT THE NEXT SCHEDULED FOLLOW-UP. THE ICD AND THE RV LEAD REMAIN IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712586 ↗
• MalfunctionJan 22, 2019Premature Discharge of Battery; Device Displays Incorrect Message; Premature Discharge of Battery; Device Displays Incorrect Message

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) BASED ON THE INFORMATION RECEIVED IS STILL IN SERVICE. AN UPDATE WILL BE PROVIDED IN THE FINAL REPORT. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8268842 ↗

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-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-0078-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD DR, Model D433, Sterile.
• Z-0077-2018 · Oct 4, 2017 · Terminated
  RESONATE EL ICD VR, Model D432, Sterile.
• 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-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