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

Model Number	D010
Medical Device Problem Codes	Premature Discharge of Battery (1057); Delayed Charge Time (2586); Defective Device (2588); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.
Additional Manufacturer Narrative
The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.Supplemental correction to correct d6b explant date.
Event or Problem Description
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.
Additional Manufacturer Narrative
The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.Correction to h6: included device code for delayed charge times.
Event or Problem Description
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.This icd was returned for analysis.
Additional Manufacturer Narrative
The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.Supplemental correction to correct d6b explant date.Correction to h6: included device code for delayed charge times.The returned implantable cardioverter defibrillator (icd) was analyzed and an engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
Event or Problem Description
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.This icd was returned for analysis.

• 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: 15543227
• Report Number: 2124215-2022-39752
• Device Sequence Number: 5593318
• Product Code: LWS
• UDI-Device Identifier: 00802526533785
• UDI-Public: 00802526533785
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/12/2023

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: 07/23/2016
• Device Model Number: D010
• Device Catalogue Number: D010
• Device Lot Number: 103836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 10/10/2022; 09/27/2022; 06/12/2023
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/12/2022; 10/25/2022; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male