MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR / PACEMAKER LEAD

Model Number 4542

Device Problems Failure to Capture (1081); Fracture (1260); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported that this left ventricular (lv) lead was suspected to have fractured.The patient arrived at the hospital for a routine follow-up without capture on their right ventricular (rv) lead.The device was programmed with the configuration lv tip to lv ring, but this resulted in loss of capture and out-of-range impedance measurements.The configuration was changed to lv ring to can with normal pacing threshold and good and stable impedance.The plan for this patient is continued routine follow-ups.No adverse patient effects were reported.

Manufacturer Narrative

This device remains implanted; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this left ventricular (lv) lead was suspected to have fractured at the tip, resulting in out-of-range impedances and loss of capture.The issue was resolved through electronic repositioning of the lead (programming the lead tip out of the sensing/pacing configuration).The plan for this patient is continued routine follow-ups.No adverse patient effects were reported.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: DEFIBRILLATOR / PACEMAKER LEAD
• 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: 14674677
• MDR Text Key: 293952655
• Report Number: 2124215-2022-20913
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2015
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 160082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1