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

Model Number	4517
Medical Device Problem Codes	High impedance (1291); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this right ventricular (rv) lead could not be inserted all of the way into the header of the cardiac resynchronization therapy defibrillator (crt-d) during generator change out procedure.This produced shock impedance measurements that were greater than 200 ohms which was high out of range.Multiple attempts at troubleshooting were performed including cleaning the terminal pin and reinsertion.Ultimately, the physician elected to complete the procedure with the out of range measurements and re-evaluate during follow-up appointments.No adverse patient effects were reported outside of the prolonged procedure.

• Brand Name: EASYTRAK 2
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19557702
• Report Number: 2124215-2024-37089
• Device Sequence Number: 14636093
• Product Code: NIK
• UDI-Device Identifier: 00802526417665
• UDI-Public: 00802526417665
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: 05/07/2006
• Device Model Number: 4517
• Device Catalogue Number: 4517
• 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: 05/31/2024
• Initial Report FDA Received Date: 06/18/2024
• Date Device Manufactured: 05/07/2004
• 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: 87 YR
• Patient Sex: Male