INOGEN™ MINI ICD VR D010Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI 00802526533785), received between Apr 21, 2016 and Apr 17, 2025 — classified as 2 deaths, 93 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (33 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 25 most recent of 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2025High impedance; Incorrect, Inadequate or Imprecise Result or Readings; High impedance; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING A RETROSPECTIVE REVIEW OF DEVICE DATA IT WAS IDENTIFIED THAT DURING A SHOCK DELIVERY, THIS SYSTEM RECORDED A CODE 1005 INDICATIVE OF HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 145 OHMS. NO OTHER INFORMATION WAS PROVIDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856943 ↗
• MalfunctionApr 17, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE STATED THAT THEIR REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON, AND THIS COMMUNICATOR WAS NOT CONNECTING. TROUBLESHOOTING WAS PERFORMED AND THE PATIENT WAS GOING TO INVESTIGATE LANDLINE AND TRY TO GET IT WORKING AS IT WAS SUSPECTED THAT THE LANDLINE WAS NOT WORKING. THE PATIENT WAS REFERRED TO THE CLINIC. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128033 ↗
• MalfunctionJan 10, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS RECEIVED BY POST MARKET QUALITY ASSURANCE WITHOUT A KNOWN REASON FOR EXPLANT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489040 ↗
• MalfunctionNov 16, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT FROM 1.5 YEARS LONGEVITY REMAINING TO SIX MONTHS REMAINING IN A SPAN OF EIGHT MONTHS AND THEN THE DAY AFTER, THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THIS DEVICE WENT BY CHARGE TIME. TS ALSO STATED THAT THIS DEVICE WILL HAVE THE 90-DAY ERI TO END OF LIFE (EOL) WINDOW, BUT IF THERAPY IS NEEDED, CHARGE TIME WILL BE MORE THAN 15 SECONDS. TO DATE, THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18149324 ↗
• InjuryNov 3, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS DEVICE DELIVERED 5 ROUNDS OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND 4 INAPPROPRIATE SHOCKS DUE TO AN EPISODE OF ATRIAL ARRYTHMIA. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 18065697 ↗
• InjuryOct 27, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD. UPON REVIEW, IT WAS NOTED THAT THE SHOCK MEASUREMENTS HAVE BEEN HIGH FOR THE PAST YEARS. ALSO, WAS OBSERVED THAT THIS ICD REACHED A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI). A SAVE TO DISK WAS SENT IN FOR ENGINEERING ANALYSIS AND IT WAS CONFIRMED THAT THIS ICD IS DEPLETING NORMALLY AND THE ERI WAS DECLARED DUE TO HIGH VOLTAGES CHARGES IN EXCESS OF 15 SECONDS CONSUMPTION. THIS IS A SECONDARY MECHANISM FOR SETTING ERI AND IS NOT TRACKED BY THE LONGEVITY CALCULATION ALGORITHM. ENGINEERING ANALYSIS CONFIRMS 90-DAY ERI TO EOL (END OF LIFE) IN CASE MORE TIME IS NEEDED. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS SURGICALLY ABANDONED, WHILE THE ICD WAS EXPLANTED. BOTH PRODUCTS WERE SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18023281 ↗
• InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 17594846 ↗
• InjuryMay 31, 2023High impedance; High impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD HIGH SHOCK IMPEDANCE ON THE RIGHT VENTRICULAR (RV) CHANNEL. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED TROUBLESHOOTING ACTIONS, SUCH AS A COMMANDED SHOCK. THE COMMANDED SHOCK WAS CONFIRMED. IT WAS NOTED THAT THE IMPEDANCE VALUE WAS WITHIN RANGE. THE PATIENT WILL CONTINUE TO BE MONITORED. THE DEVICE REMAINS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: Electric Shock

  MAUDE report 17032009 ↗
• InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16811840 ↗
• MalfunctionMar 23, 2023High impedance; High impedance

  IT WAS REPORTED THAT AN ALERT FOR A HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) SHOCK IMPEDANCE MEASUREMENT FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS OBSERVED. THIS S-ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600127 ↗
• InjuryMar 6, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. A REVISION PROCEDURE WAS PERFORMED AND THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486624 ↗
• InjuryFeb 14, 2023Premature Discharge of Battery; Noise, Audible; Premature Discharge of Battery; Noise, Audible

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. THE PACEMAKER WAS NOTED TO HAVE AUDIBLE TONES AND WAS IN END OF LIFE (EOL), LEADING TO DEVICE REPLACEMENT. THIS ICD WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374078 ↗
• MalfunctionFeb 3, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH IMPEDANCES OUT OF RANGE. THE CLINIC PERSONNEL MENTIONED THE PATIENT WILL BE IN CONTINUE MONITORING. THIS ICD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292523 ↗
• InjuryJan 9, 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 THERE WERE CONCERNS REGARDING ALLEGED PREMATURE BATTERY WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AT THE LAST FOLLOW-UP, THIS DEVICE SHOWED ONE YEAR ESTIMATED BATTERY LONGEVITY REMAINING. AT THE MOST RECENT FOLLOW-UP, THIS DEVICE TRIGGERED END OF LIFE AND INTERROGATION WAS NOT POSSIBLE. SUBSEQUENTLY, THIS DEVICE WAS EXPLANTED AND REPLACED IMMEDIATELY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120795 ↗
• InjuryJan 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO STAPHYLOCOCCUS AUREUS ENDOCARDITIS INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PACEMAKER WAS EXPLANTED.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 16081441 ↗
• InjuryDec 8, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED HIGH SHOCK LEAD IMPEDANCES OUT ORANGE. THE IMPEDANCE WAS GRADUALLY INCREASING. A LEAD CALCIFICATION WAS SUSPECTED. COMMANDED SHOCK WAS PERFORMED BEFORE THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION, TO TEST THE IMPEDANCE MEASUREMENTS TO AVOID 1005 FAULT CODE. THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 15946654 ↗
• InjuryNov 21, 2022Failure to Convert Rhythm; Inaccurate Synchronization; Failure to Convert Rhythm; Inaccurate Synchronization

  IT WAS REPORTED THAT THIS PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT). THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND ONE 41 JOULE SHOCK. AFTER THE SHOCK, THE PATIENT'S RHYTHM ACCELERATED TO VENTRICULAR FIBRILLATION (VF). THE NEXT SEVEN SHOCKS FAILED TO CONVERT THE RHYTHM AND THERAPY WAS EXHAUSTED. THIS PATIENT WAS HOSPITALIZED AND REQUIRED EXTERNAL DEFIBRILLATION. TECHNICAL SERVICES (TS) ANALYZED DEVICE EPISODE DATA AND RECOMMENDED A DUAL COIL TACHY LEAD. IT WAS NOTED THAT DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS ICD REMAINS IN SERVICE.

  Patient problems: Ventricular Fibrillation

  MAUDE report 15833509 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE ICD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 15712141 ↗
• InjuryOct 24, 2022Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time; Premature Discharge of Battery; Incorrect, Inadequate or Imprecise Result or Readings; Delayed Charge Time

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. ALSO REPORTED THAT THIS DEVICE HAD REACHED A BATTERY STATUS INDICATOR OF EXPLANT. THE EXPLANT INDICATOR WAS FOUND TO BE DUE TO EXTENDED CHARGE TIMES. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AT THIS TIME, IT IS UNKNOWN IF THIS DEVICE WILL RETURN FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15657825 ↗
• InjuryOct 12, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT A HEALTHCARE PROVIDER (HCP) CONTACTED A BOSTON SCIENTIFIC FIELD REPRESENTATIVE STATING THAT THIS SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE HAD ONE YEAR OF LONGEVITY REMAINING AT LAST DEVICE CHECK BUT RECENTLY REACHED ELECTIVE REPLACEMENT INTERVAL (ERI) STATUS. BOSTON SCIENTIFIC ENGINEERING ANALYSIS OF DEVICE DATA WAS COMPLETED AND CONFIRMED THAT THE DEVICE BATTERY WAS DEPLETING NORMALLY, AND ERI STATUS WAS REACHED DUE TO TWO CAPACITOR CHARGE TIMES IN EXCESS OF 15 SECONDS. THIS IS A SECONDARY MECHANISM OF THE DEVICE TO REACH ERI, IN ADDITION TO LONGEVITY CALCULATORS, TO ENSURE THERAPY REMAINS AVAILABILITY TO THE PATIENT. THE ANALYSIS ALSO INDICATED THAT A NORMAL ERI STATUS TO END OF LIFE (EOL) STATUS REPLACEMENT INTERVAL OF 90 DAYS IS EXPECTED. ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED THAT A DIFFERENT BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS TOLD THIS DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE REPRESENTATIVE NOTICED THE CAPACITOR CHARGE TIME WAS 17 SECONDS. AS A RESULT, THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588625 ↗
• InjuryOct 5, 2022Premature Discharge of Battery; Delayed Charge Time; Defective Device; Battery Problem; Premature Discharge of Battery; Delayed Charge Time; Defective Device; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED DEVICE LONGEVITY FROM ONE AND A HALF YEARS TO ELECTIVE REPLACEMENT INDICATOR (ERI) IN A SPAN OF SIX MONTHS. DATA ANALYSIS DETERMINED THAT THE DEVICE IS DEPLETING NORMALLY. ERI WAS DECLARED DUE TO TWO HIGH VOLTAGE CHARGES IN EXCESS OF FIFTEEN SECONDS. THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543227 ↗
• InjurySep 24, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOWED ELEVEN MONTHS OF BATTERY REMAINING THEN IT TRIPPED ELECTIVE REPLACEMENT INDICATOR (ERI). DATA ANALYSIS INDICATED THAT THE DEVICE WAS DEPLETING NORMALLY AND ERI WAS DECLARED DUE TO TWO HV CHARGES. THIS IS A SECONDARY MECHANISM FOR SETTING ERI AND IS NOT TRACKED BY THE LONGEVITY CALCULATION ALGORITHM. THIS DEVICE IS AN OUTLIER IN CHARGING PERFORMANCE BUT IS NOT MALFUNCTIONING. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED DUE TO PREMATURE BATTERY DEPLETION (PBD). A NEW DEVICE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15477213 ↗
• MalfunctionAug 22, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DUE TO ATRIAL FIBRILLATION. TECHNICAL SERVICES (TS) SUGGESTED REPROGRAMMING OPTIONS. AT THIS TIME, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. THIS PRODUCT REMAINS IN SERVICE. IT WAS REPORTED THAT THIS ICD DELIVERED AN INAPPROPRIATE ELECTRIC SHOCK DUE TO ATRIAL FIBRILLATION. ADDITIONALLY, IT WAS NOTED THAT THIS ICD DISPLAYED BATTERY CAPACITY DEPLETED (BCD). FURTHERMORE, THE PATIENT HAD RECEIVED INAPPROPRIATE SHOCKS PRIOR TO THIS INCIDENT. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED AND THIS PRODUCT REMAINS IN SERVICE.

  Patient problems: Electric Shock

  MAUDE report 15265975 ↗
• InjuryAug 3, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) FROM 11 MONTHS REMAINING TWO WEEKS AGO. DATA ANALYSIS CONFIRMED THAT ERI WAS DECLARED DUE TO TWO HIGH VOLTAGE CHARGES IN EXCESS OF 15 SECONDS. THE DEVICE WAS DEPLETING NORMALLY. THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED DUE TO A UNKNOWN PRODUCT PERFORMANCE ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15155384 ↗
• InjuryJul 21, 2022Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time; Inappropriate/Inadequate Shock/Stimulation; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING THREE INAPPROPRIATE SHOCKS FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS NOTED THAT THIS ICD HAD REACHED BATTERY CELL DEPLETION ON (B)(6) 2022. A 21-SECOND CHARGE TIME WAS NOTED FOR THE DELIVERED SHOCKS. THE PATIENT WAS ADMITTED TO THE HOSPITAL UNTIL THE ICD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: Electric Shock

  MAUDE report 15080790 ↗

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-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-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