MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	D010
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
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.
Additional Manufacturer Narrative
The device has been returned for analysis.This report will be updated upon completion of analysis.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.A review of device memory indicated there were no faults or resets.In addition, battery voltage was appropriate and normal power usage occurred while the device was implanted.All device therapy was available while the device was implanted.Analysis is consistent with normal battery depletion.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device issue that would have caused or contributed to the reported clinical observations.

• Brand Name: INOGEN MINI ICD VR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15588625
• Report Number: 2124215-2022-41060
• Device Sequence Number: 7149252
• Product Code: LWS
• UDI-Device Identifier: 00802526533785
• UDI-Public: 00802526533785
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/12/2016
• Device Model Number: D010
• Device Catalogue Number: D010
• Device Lot Number: 102387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male