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

Model Number	D012
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded atrial tachy response (atr) episodes due to possible respiratory rate trend (rrt) oversensing.Technical services reviewed the case and stated that the rrt feature was on, but this icd did not have the newest firmware that adds the signal artifact monitoring (sam) feature and recommended to bring the patient for in-clinic interrogation.Sam should be downloaded to this device.No erratic or high impedance was noticed.Further information was received indicating that the firmware was updated, and the atrs were confirmed to be caused due to rrt oversensing.This icd remained in service and was eventually explanted and replaced due to a normal battery depletion.The product was returned for analysis.No adverse patient effects were ever reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.The baseline functions were tested, and it operated appropriately, according to its performance specifications.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.However, investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to intermittent increases in impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection.A compromised lead or inadequate device-lead connection has the potential to create a transient high impedance condition, which may alter the minute ventilation sensor signal such that it becomes visible on egms and potentially subject to oversensing on the ra or rv channels.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)
• 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: 18268478
• Report Number: 2124215-2023-68851
• Device Sequence Number: 12727548
• Product Code: LWS
• UDI-Device Identifier: 00802526533822
• UDI-Public: 00802526533822
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/27/2018
• Device Model Number: D012
• Device Catalogue Number: D012
• Device Lot Number: 108447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male