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

Model Number	D013
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the respiratory rate sensor was being oversensed on this implantable cardioverter defibrillator (icd).This resulted in inappropriate mode switching.The sensor was programmed off.No adverse patient effects were reported.This product remains in service.This report will be updated, should additional information be received.
Event or Problem Description
Additional information was reported indicating that the clinic now has 5 instances of daily measurements on the ra lead, that are greater than 3000 ohms.The health care professional (hcp) did extensive testing with no out of range impedances and no noise on the electrograms (egm).The hcp will continue to monitor and watch for what may be a true fracture, should it occur.The ra lead is from another manufacturer.No adverse patient effects were reported.This report will be updated, should additional information be received.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8720113
• Report Number: 2124215-2019-12065
• Device Sequence Number: 14049971
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 08/11/2017
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 245576
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 01/07/2020
• 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