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

Model Number	D011
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The return of the product was requested.If the product is returned, product investigation will be performed, and this complaint would be updated upon analysis completion.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited premature battery depletion (pbd).The device was explanted and no additional adverse patient effects were reported.
Additional Manufacturer Narrative
The return of the product was requested.If the product is returned, product investigation will be performed, and this complaint would be updated upon analysis completion.Upon receipt at our post market quality assurance laboratory, a review of memory noted no suspicious fault codes or resets while implanted.The pulse generator pg diagnostic data spreadsheet graph shows a cell depletion pattern that is consistent with normal battery depletion.The device passed the longevity calculation with a lifetime longevity of 135.3 percent.Device implanted for 8.21 years.Elective replacement indicator eri or end of life eol interval is 92 days.Passing is 90 days.The no problem detected conclusion code was selected based on analysis of the returned product.Analysis found no evidence of device defect, malfunction or damage outside the bounds of normal medical use.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited premature battery depletion (pbd).The device was explanted.No additional adverse patient effects were reported.

• 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: 16005123
• Report Number: 2124215-2022-53387
• Device Sequence Number: 6656034
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 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): 06/09/2023

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: 07/30/2016
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 437626
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2014
• 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: Male