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

Model Number 4543

Device Problems Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291)

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

Event Date 01/27/2024

Event Type  malfunction  

Event Description

It was reported that this left ventricular (lv) lead exhibited high out range pacing impedance measurements of greater than 3000ohms.The field representative requested technical services (ts) to review the device electrogram (egm).Review of the presenting egm found high rates of lv sense likely due to noise.The lv lead was configured lv tip to right ventricular (rv) and the shock lead impedances appeared to be normal.Ts suspected that the cause of the high out of range impedances to be a lv tip issue and provided programming options.No adverse patient effects were reported.At this time, the lead remains in service.

Event Description

It was reported that this left ventricular (lv) lead exhibited high out range pacing impedance measurements of greater than 3000ohms.The field representative requested technical services (ts) to review the device electrogram (egm).Review of the presenting egm found high rates of lv sense likely due to noise.The lv lead was configured lv tip to right ventricular (rv) and the shock lead impedances appeared to be normal.Ts suspected that the cause of the high out of range impedances to be a lv tip issue and provided programming options.No adverse patient effects were reported.At this time, the lead remains in service.Subsequent additional information was provided by the field representative that based on the lead diagnostic findings, the physician suspected the lv lead to have been fractured.The lv lead was reprogrammed, and the issue was resolved.No additional adverse patient effects were reported.The lv lead remains in service.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: 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: 18716783
• MDR Text Key: 335554348
• Report Number: 2124215-2024-09141
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/21/2014
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 176612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2012
• 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
• Patient Age: 70 YR
• Patient Sex: Male