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

Model Number 4542

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); High Capture Threshold (3266)

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

Event Date 10/20/2023

Event Type  Injury  

Event Description

It was reported that the health care professional (hcp) called to report that this cardiac resynchronization therapy defibrillator (crt-d) recorded a high out of range impendence on the left ventricular (lv) lead.The patient was brought into the clinic for an in person visit and lead measurements were taken came back normal and within range.However, another high out of range impendence alert was recorded after the visit.The hcp called technical services (ts) to review the stored data.Ts reviewed the presented electrogram (egm) and lv loss of capture (loc) was noted.Ts recommended for further lead testing be performed.The lv lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that the health care professional (hcp) called to report that this cardiac resynchronization therapy defibrillator (crt-d) recorded a high out of range impendence on the left ventricular (lv) lead.The patient was brought into the clinic for an in person visit and lead measurements were taken came back normal and within range.However, another high out of range impendence alert was recorded after the visit.The hcp called technical services (ts) to review the stored data.Ts reviewed the presented electrogram (egm) and lv loss of capture (loc) was noted.Ts recommended for further lead testing be performed.The lv lead remains in service.No adverse patient effects were reported.Subsequent additional information was received reported that this left ventricular (lv) lead exhibited high pacing threshold, high out of range impedance measurements and loss of capture (loc).A chest xray imaging was done indicated possible fracture.The physician performed a lead revision procedure, where the lv lead was surgically abandoned and the crtd device was explanted.The crtd and lv lead were successfully replaced with a new device and lead.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: 18107598
• MDR Text Key: 328632426
• Report Number: 2124215-2023-63268
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2014
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 154528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2012
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male