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

Model Number	D013
Medical Device Problem Codes	Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had reached a battery status indicator of explant.The battery status in september indicated 11 months remaining to explant while in december, the device triggered elective replacement indicator (eri).The explant indicator was found to be due to extended charge times.Technical services discussed and recommended device replacement.Subsequently, the device was explanted and replaced.No additional 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.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) had reached a battery status indicator of explant.The battery status in september indicated 11 months remaining to explant while in december, the device triggered elective replacement indicator (eri).The explant indicator was found to be due to extended charge times.Technical services discussed and recommended device replacement.Subsequently, the device was explanted and replaced.No additional 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.
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported delayed charge time and gas gauge not as expected.

• Brand Name: INOGEN MINI ICD DR
• 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: 11669410
• Report Number: 2124215-2021-07294
• Device Sequence Number: 11604779
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2022

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: 04/24/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 101323
• 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: 03/16/2021
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 03/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2014
• 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: 83 YR
• Patient Sex: Female