MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD DR; PACEMAKER

Model Number	D142
Medical Device Problem Codes	High impedance (1291); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that implantable cardioverter defibrillator (icd) and right ventricular (rv) lead exhibited shock impedance measurements high out of range greater than 125 ohms.Technical services (ts) reviewed and provided troubleshooting options to perform in clinic.Ts stated lead replacement should be consider if the measurements reach greater than 150 ohms.It was noted that the pacing impedance measurements also follow this patter; however, not out of range.This icd and rv lead remain in service.No adverse patient effects were reported.

• Brand Name: INOGEN? EL ICD DR
• Common Device Name: PACEMAKER
• 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: 25272482
• Report Number: 2124215-2026-27999
• Device Sequence Number: 15878927
• Product Code: LWS
• UDI-Device Identifier: 00802526534249
• UDI-Public: (01)00802526534249(17)200117
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 01/17/2020
• Device Model Number: D142
• Device Catalogue Number: D142
• Device Lot Number: 540948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 05/25/2026
• Supplement Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 02/02/2018
• 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: 53 YR
• Patient Sex: Female