MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN? EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	D141
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range impedance measurements for its non boston scientific right ventricular (rv) lead, so alerts were generated.Technical services (ts) was consulted and discussed stored data, with possible root causes been a spring contract issue or a lead fracture.Ts discussed troubleshooting options.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range impedance measurements for its non boston scientific right ventricular (rv) lead, so alerts were generated.Technical services (ts) was consulted and discussed stored data, with possible root causes been a spring contract issue or a lead fracture.Ts discussed troubleshooting options.This device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent changes in impedance measurements with no conclusive evidence of a product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Engineering analysis and testing of returned products has determined that repeated, small movements of the lead terminal ring along with variances in the connection contact force and surface roughness can impact the connection between the spring contact and the lead ring, resulting in intermittent changes in impedance measurement.

• Brand Name: INOGEN? EL ICD VR
• 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 ; 6515826168
• MDR Report Key: 22006224
• Report Number: 2124215-2025-30463
• Device Sequence Number: 9099319
• Product Code: LWS
• UDI-Device Identifier: 00802526534225
• UDI-Public: (01)00802526534225(17)210911
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/25/2025

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: 09/11/2021
• Device Model Number: D141
• Device Catalogue Number: D141
• Device Lot Number: 205835
• 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: 04/28/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/25/2025
• Date Device Manufactured: 09/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Male