MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D012
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was dead.Boston scientific technical services (ts) referred to the attending physician to clarify the meaning of device being dead.This device was surgically explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.This supplemental correction report was created to capture the additional information received which indicated that the device was at elective replacement indicator (eri) which was referred to as device dead by the clinic.This observation no longer meets the definition of malfunction as it was confirmed that the device was operating normally.Amending mdr decision to mdr=no report.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was dead.Boston scientific technical services (ts) referred to the attending physician to clarify the meaning of device being dead.This device was surgically explanted and replaced.No additional adverse patient effects were reported.Additional information received indicated that the icd device was found to be at elective replacement indicator (eri).The field representative explained that most likely when eri was discovered in clinic the staff referred to the device as dead.Generator change was completed with no adverse patient effects.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) was dead.Boston scientific technical services (ts) referred to the attending physician to clarify the meaning of device being dead.This device was surgically explanted and replaced.No additional adverse patient effects were reported.Additional information received indicated that the icd device was found to be at elective replacement indicator (eri).The field representative explained that most likely when eri was discovered in clinic the staff referred to the device as dead.Generator change was completed with no adverse patient effects.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Detailed analysis did not confirm the reported allegation.Having met the engineering longevity prediction, automatically and functionally passed all returned product testing, and with no further information to indicate a product performance issue.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.This supplemental correction report was created to capture the additional information received which indicated that the device was at elective replacement indicator (eri) which was referred to as device dead by the clinic.This observation no longer meets the definition of malfunction as it was confirmed that the device was operating normally.Amending mdr decision to mdr=no report.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16386626
• Report Number: 2124215-2023-07116
• Device Sequence Number: 5514744
• Product Code: LWS
• UDI-Device Identifier: 00802526533822
• UDI-Public: 00802526533822
• 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: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2025

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: 08/18/2017
• Device Model Number: D012
• Device Catalogue Number: D012
• Device Lot Number: 107093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 02/17/2023; 01/08/2025
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 02/20/2023; 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2015
• 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: 83 YR
• Patient Sex: Female