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

Model Number	D013
Medical Device Problem Codes	Premature Discharge of Battery (1057); Pacing Problem (1439); Delayed Charge Time (2586); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely.Three months prior to the aware date the device showed eleven months until explant, on the aware date the device was at battery capacity depleted (bcd).Review of the activity of the device was performed.And it was determined that the cap reform was over fifteen seconds and a tomography scan were performed on this patient.This induced the depletion of the battery on this device.This device is not delivering brady pacing.Device replacement was recommended.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be depleting prematurely.Three months prior to the aware date the device showed eleven months until explant, on the aware date the device was at battery capacity depleted (bcd).Review of the activity of the device was performed.And it was determined that the cap reform was over fifteen seconds, and a tomography scan were performed on this patient.This induced the depletion of the battery on this device.This device is not delivering brady pacing.Device replacement was recommended.This device remains in service.No adverse patient effects were reported.Additional information was received confirming this device was explanted and replaced.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE 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: 15807255
• Report Number: 2124215-2022-47470
• Device Sequence Number: 20238095
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

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: 08/18/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 102911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2014
• 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: 88 YR
• Patient Sex: Male