INOGEN MINI ICD DRRecalls & reported problems across all models

We found 2 models of INOGEN MINI ICD DR by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 160 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2016 and Dec 5, 2023 — classified as 110 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (34 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported INOGEN MINI ICD DR problems

INOGEN MINI ICD DR models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INOGEN™ MINI ICD DR D012

  Implantable cardioverter defibrillator (non-CRT)
  109 reports
• INOGEN™ MINI ICD DR D013

  Implantable cardioverter defibrillator (non-CRT)
  51 reports

Recent INOGEN MINI ICD DR adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2023Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED ATRIAL TACHY RESPONSE (ATR) EPISODES DUE TO POSSIBLE RESPIRATORY RATE TREND (RRT) OVERSENSING. TECHNICAL SERVICES REVIEWED THE CASE AND STATED THAT THE RRT FEATURE WAS ON, BUT THIS ICD DID NOT HAVE THE NEWEST FIRMWARE THAT ADDS THE SIGNAL ARTIFACT MONITORING (SAM) FEATURE AND RECOMMENDED TO BRING THE PATIENT FOR IN-CLINIC INTERROGATION. SAM SHOULD BE DOWNLOADED TO THIS DEVICE. NO ERRATIC OR HIGH IMPEDANCE WAS NOTICED. FURTHER INFORMATION WAS RECEIVED INDICATING THAT THE FIRMWARE WAS UPDATED, AND THE ATRS WERE CONFIRMED TO BE CAUSED DUE TO RRT OVERSENSING. THIS ICD REMAINED IN SERVICE AND WAS EVENTUALLY EXPLANTED AND REPLACED DUE TO A NORMAL BATTERY DEPLETION. THE PRODUCT WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE EVER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268478 ↗
• InjurySep 28, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THERE IS A CONCERN FOR A SUSPECTED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY FROM THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PERFORMED AN ANALYSIS IN WHICH IT WAS DETERMINED THAT THERE MAY BE INAPPROPRIATE THERAPY FOR A SUPRAVENTRICULAR TACHYCARDIA. IT WAS ALSO NOTED THAT THERAPY EXHAUSTION OCCURRED; TS RECOMMENDED PROGRAMMING ENHANCEMENTS. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Electric Shock

  MAUDE report 17840388 ↗
• InjuryJul 3, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A YELLOW ALERT 1007 RELATED TO CAPACITOR CHARGE TIME EXCEEDING THE LIMIT. THE DEVICE WAS RECOMMENDED TO BE EXPLANTED AND HAS BEEN EXPLANTED AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245120 ↗
• MalfunctionJun 26, 2023Signal Artifact/Noise; High impedance; Noise, Audible; Signal Artifact/Noise; High impedance; Noise, Audible

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED NOISE AND HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR CHANNEL. ADDITIONALLY, THE DEVICE STARTED EMITTING AUDIBLE TONES DUE TO HAVING REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). TROUBLESHOOTING, MONITORING AND A POTENTIAL DEVICE REPLACEMENT WERE DISCUSSED. AT THIS TIME, THIS DEVICE REMAINS IN SERVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203860 ↗
• InjuryMar 31, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD CHANGEOUT AS THE DEVICE WAS DEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) HAS NO FURTHER INFORMATION. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656696 ↗
• InjuryFeb 20, 2023Signal Artifact/Noise; Low impedance; Signal Artifact/Noise; Low impedance

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR CHANNEL AND NOISE ON THE RIGHT ATRIAL CHANNEL. FURTHER REVIEW OF THE DEVICE WAS DISCUSSED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404832 ↗
• InjuryFeb 16, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS DEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REFERRED TO THE ATTENDING PHYSICIAN TO CLARIFY THE MEANING OF DEVICE BEING DEAD. THIS DEVICE WAS SURGICALLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386626 ↗
• InjuryJan 2, 2023Premature Discharge of Battery; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A CHARGE TIME OF OVER FIFTEEN SECONDS. DUE TO THIS, THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THIS DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16082672 ↗
• InjuryNov 16, 2022Premature Discharge of Battery; Pacing Problem; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Pacing Problem; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO BE DEPLETING PREMATURELY. THREE MONTHS PRIOR TO THE AWARE DATE THE DEVICE SHOWED ELEVEN MONTHS UNTIL EXPLANT, ON THE AWARE DATE THE DEVICE WAS AT BATTERY CAPACITY DEPLETED (BCD). REVIEW OF THE ACTIVITY OF THE DEVICE WAS PERFORMED. AND IT WAS DETERMINED THAT THE CAP REFORM WAS OVER FIFTEEN SECONDS, AND A TOMOGRAPHY SCAN WERE PERFORMED ON THIS PATIENT. THIS INDUCED THE DEPLETION OF THE BATTERY ON THIS DEVICE. THIS DEVICE IS NOT DELIVERING BRADY PACING. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THIS DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807255 ↗
• InjuryNov 3, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE IS EXHIBITING POTENTIAL PREMATURE BATTERY DEPLETION BEHAVIOR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THAT THE DEVICE RECENTLY REACHED EXPLANT INDICATOR STATUS DUE TO A CAPACITOR CHARGE TIME OF 16.2 SECONDS. TS NOTED THAT THE DEVICE WILL STILL HAVE A 90 DAY REPLACEMENT WINDOW BUT THEY COULD CONSIDER REPLACING THE DEVICE SOONER DUE TO THE EXTENDED CHARGE TIME. TS OFFERED TO PERFORM AN ANALYSIS OF DEVICE DATA, BUT THE HEALTHCARE PROVIDER STATED THEY WILL INFORM THE PHYSICIAN AND GO FROM THERE. THE DEVICE REMAINS IN-SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS ICD DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15722228 ↗
• InjuryOct 12, 2022Premature Discharge of Battery; Delayed Charge Time; Battery Problem; Premature Discharge of Battery; Delayed Charge Time; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAS REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED CHARGE TIME CRITERIA TO DECLARE ELECTIVE REPLACEMENT INDICATOR (ERI). ADDITIONAL INFORMATION WAS OBTAINED, AND THE REPRESENTATIVE STATED THAT A LONGEVITY ISSUE WAS NOTED ALONG WITH LONG CHARGE TIMES. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587282 ↗
• InjurySep 6, 2022Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD REACHED A BATTERY CAPACITY DEPLETED STATUS FOR APPROXIMATELY ONE YEAR. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED THIS WAS FOUND TO BE DUE TO EXTENDED CHARGE TIMES AND RECOMMENDED DEVICE REPLACEMENT. CURRENTLY, EVIDENCE SUGGESTS THAT THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366162 ↗
• InjuryJun 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE BATTERY LONGEVITY OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WENT FROM NINE MONTHS REMAINING TO ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS IN A SPAN OF ONE MONTH. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED OPTION DOING SAVE TO DISK AND SENDING FILE. ADDITIONAL INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14690533 ↗
• InjuryJun 1, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEPLETED QUICKER THAN EXPECTED WITH 11 MONTHS REMAINING LEFT. ALSO, THIS DEVICE BEEPED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570334 ↗
• InjuryApr 26, 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 14214627 ↗

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