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

Model Number 4542

Device Problems Failure to Capture (1081); High impedance (1291); Defective Device (2588)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead exhibited high out-of-range pace impedance measurements and loss of capture at high outputs.Subsequently, the patient was admitted into the hospital and x-ray imaging was obtained, which showed an anomaly at the height of the atrium.It was noted that the patient underwent unrelated cardiac surgery in (b)(6) 2020 at another hospital, and the physician suspects the lv lead may have been accidentally damaged during the procedure.At this time, a lead fracture is suspected by the physician, who has requested boston scientific technical services (ts) consultation.In the meantime, the patient is being closely followed via the latitude remote patient monitoring system, and this lv lead remains implanted and in service.There were no adverse patient effects reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this left ventricular (lv) lead exhibited high out-of-range pace impedance measurements and loss of capture at high outputs.Subsequently, the patient was admitted into the hospital and x-ray imaging was obtained, which showed an anomaly at the height of the atrium.It was noted that the patient underwent unrelated cardiac surgery in (b)(6) 2020 at another hospital, and the physician suspects the lv lead may have been accidentally damaged during the procedure.At this time, a lead fracture is suspected by the physician, who has requested boston scientific technical services (ts) consultation.In the meantime, the patient is being closely followed via the latitude remote patient monitoring system, and this lv lead remains implanted and in service.There were no adverse patient effects reported.Ts reviewed available x-ray images and confirmed the lv lead appeared fractured at the level of the right atrium.Subsequently, the lead was deactivated, and this patient later underwent a system revision procedure.No additional adverse patient effects were reported.At this time, it is unclear if the lead was surgically capped/abandoned or explanted, and attempts to obtain this information were unsuccessful.Therefore, product return is not expected.Should additional information be provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 11182245
• MDR Text Key: 227201801
• Report Number: 2124215-2021-00541
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: 04/24/2014
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 152665
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention