MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; IMPLANTABLE LEAD

Model Number	4543
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited pacing impedance values of greater than 3000 ohms on all tested vector configurations.Patient experienced stimulation during lv lead vector testing.It was noted that patient had an echocardiogram.Technical services (ts) analyzed presenting electrogram (egm) and found that there was no loss of capture.Subsequently, ts provided troubleshooting including testing impedances measurements on other vectors.Lead replacement was recommended.Patient is scheduled for an echocardiogram.No additional adverse patient effects were reported.Currently, this lead remains in service.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance.Measurements were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this left ventricular (lv) lead exhibited pacing impedance values of greater than 3000 ohms on all tested vector configurations.Patient experienced stimulation during lv lead vector testing.It was noted that patient had an echocardiogram.Technical services (ts) analyzed presenting electrogram (egm) and found that there was no loss of capture.Subsequently, ts provided troubleshooting including testing impedances measurements on other vectors.Lead replacement was recommended.Patient is scheduled for an echocardiogram.No additional adverse patient effects were reported.Currently, this lead remains in service.Later, this product was received by boston scientific and full investigation was conducted.

• Brand Name: EASYTRAK 2 IS-1
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15759755
• Report Number: 2124215-2022-46276
• Device Sequence Number: 6227116
• Product Code: NIK
• UDI-Device Identifier: 00802526579813
• UDI-Public: 00802526579813
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 08/03/2017
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 190782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2015
• 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 Sex: Male