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

Model Number	D012
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the respiratory sensor that is related to intermittent increases in impedance measurements.Engineering analysis and testing of returned products has identified that any repeated, small movements of the lead terminal ring can create wearing of the lead terminal ring and generate microscopic particles, which may accumulate and oxidize over time.This can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurements.Please refer to the description field for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that the patient received an inappropriate shock due to atrial fibrillation (af) with rapid conduction.Anti-tachycardia pacing (atp) and four shock were delivered, but the rate gradually slowed on its own.Boston scientific technical services (ts) was contacted, and ts noted respiratory rate trend (rrt) oversensing and that the device was at elective replacement indicator (eri).The device and leads remain in service.No adverse patient effects were reported.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12749647
• Report Number: 2124215-2021-34209
• Device Sequence Number: 20063745
• Product Code: LWS
• UDI-Device Identifier: 00802526533822
• UDI-Public: 00802526533822
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 08/25/2016
• Device Model Number: D012
• Device Catalogue Number: D012
• Device Lot Number: 104424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR