MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD DR; Implantable Cardioverter Defibrillator

Model Number	D142
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range pace impedance measurements, with the patient experiencing atrial flutter the same day.Technical services (ts) was consulted and determined the events were unrelated.Ts further determined the impedance behavior appeared to be a spring contact issue due to the device header being older and a non-boston scientific lead was implanted in the system.Ts noted that impedance spikes had previously occurred; however, the device has continued to function as programmed and the system will continue to be monitored.No adverse patient effects were reported.This icd remains in service.

• Brand Name: INOGEN? EL 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 ; +1(651)582-6168
• MDR Report Key: 25580234
• Report Number: 2124215-2026-33100
• Device Sequence Number: 15724143
• Product Code: LWS
• UDI-Device Identifier: 00802526534249
• UDI-Public: (01)00802526534249(17)170930
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2026

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: 09/30/2017
• Device Model Number: D142
• Device Catalogue Number: D142
• Device Lot Number: 508420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 08/20/2026
• Date Device Manufactured: 09/30/2015
• 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
• Patient Age: 52 YR
• Patient Sex: Female