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

Model Number 4542

Device Problems Fracture (1260); High impedance (1291)

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

Event Date 08/20/2022

Event Type  Injury  

Event Description

It was reported that both non-boston scientific right atrial (ra) lead and right ventricular (rv) lead exhibited noise.Upon review, it was noted that this cardiac resynchronization therapy defibrillator (crt-d) displayed high out-of-range shock impedance measurements on the left ventricular (lv) lead due to the lv lead being chronically fractured.Which led to noise on both ra and rv leads.Isometric testing was performed and it was noted that the noise on the rv lead was oversensed.Reprogramming efforts were performed and troubleshooting options were discussed and recommended.At this time, the crt-d system remains in service and no adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields to capture the explant of the device:.

Event Description

It was reported that both non-boston scientific right atrial (ra) lead and right ventricular (rv) lead exhibited noise.Upon review, it was noted that this cardiac resynchronization therapy defibrillator (crt-d) displayed high out-of-range shock impedance measurements on the left ventricular (lv) lead due to the lv lead being chronically fractured.Which led to noise on both ra and rv leads.Isometric testing was performed and it was noted that the noise on the rv lead was oversensed.Reprogramming efforts were performed and troubleshooting options were discussed and recommended.A revision procedure was performed and all crt-d system was explanted and replaced.No additional adverse patient effects were reported.

• 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: 15460272
• MDR Text Key: 300319517
• Report Number: 2124215-2022-37125
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2011
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 135546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2009
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male