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

Model Number	4517
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Low impedance (2285); Connection Problem (2900)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left ventricular (lv) lead showed connection issues with the cardiac resynchronization therapy defibrillator (crt-d) using a lv-1 to is-1 adapter.The physician struggled to get the tip setscrew secure during the procedure.The physician screw and unscrew the lead several times and later felt it was secured.Adequate lead measurements were evidenced, and the procedure was completed.The next morning during the patient discharge, the electrogram showed flat signals on the lv channel.Technical services recommended to reprogram the lv lead polarity; however, high irregular impedance was seen reaching measurements over 3000 ohms.Technical services indicated this patient's crt-d is probably not making appropriate contact with the terminal pin of the lv lead intermittently.X-rays were recommended to evaluate this possibility.Further information was received indicating that a week later follow up, did not showed high pacing impedance measurements and no x-rays were performed.Reportedly, an infection was noticed less than 2 weeks later of the implant procedure and low pacing impedance measurements out-of-range were also noticed.The patient was admitted to the hospital due to these new issues and the lead's polarity was once again configured.More allegations were reported indicating this lv lead has showed noise with oversensing, causing pacing inhibition on just one beat.The system was reprogrammed to mitigate these issues and was scheduled for replacement due to the infection issue.Subsequently, the whole system was explanted.This lv lead is not expected to be returned and no additional adverse patient effects were reported.
Additional Manufacturer Narrative
If the product is returned, analysis would be performed and this report would be updated at that time.

• 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: 14068773
• Report Number: 2124215-2022-09638
• Device Sequence Number: 20064349
• Product Code: NIK
• UDI-Device Identifier: 00802526417665
• UDI-Public: 00802526417665
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• 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): 04/09/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/03/2008
• 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): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male