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

Model Number	D010
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.Upon 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.
Event or Problem Description
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.
Event or Problem Description
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.Further information obtained from the field indicated that the device was explanted for elective replacement indicator (eri).No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Detailed analysis did not confirmed gas gauge/longevity not as expected allegation.The baseline testing completed on the device found no failing conditions.All testing completed on the device passed or was not applicable, therefore no problem was detected.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.

• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15155384
• Report Number: 2124215-2022-28772
• Device Sequence Number: 5323315
• Product Code: LWS
• UDI-Device Identifier: 00802526533785
• UDI-Public: 00802526533785
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 07/07/2016
• Device Model Number: D010
• Device Catalogue Number: D010
• Device Lot Number: 103363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female