MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 2 IS-1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number 4542

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Select Signal (1582); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); High Capture Threshold (3266)

Patient Problem Dyspnea (1816)

Event Date 05/01/2018

Event Type  Injury  

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, during a routine follow-up, this left ventricular (lv) lead exhibited loss of capture at maximum outputs and high out of range pacing impedances.Sensing amplitudes had also decreased since the previous check and a lead fracture was suspected.The patient reported feeling slightly more breathless but no other adverse patient effects were reported.The patient was to be scheduled for a chest x-ray.This lv lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that, during a routine follow-up, this left ventricular (lv) lead exhibited loss of capture at maximum outputs and high out of range pacing impedances.Sensing amplitudes had also decreased since the previous check and a lead fracture was suspected.The patient reported feeling slightly more breathless but no other adverse patient effects were reported.The patient was to be scheduled for a chest x-ray.This lv lead remains in service.No adverse patient effects were reported.New information received indicates that the chest x-ray confirmed dislodgement the patient underwent surgical intervention to replace the lv lead however due to a blocked superior vena cava (svc) a new lead could not be implanted.The procedure was halted and the patient was scheduled for an svc stent/balloon procedure with a vascular surgeon.In the meantime the patient's health deteriorated which is not believed to be related to this lv lead malfunction.The associated device was deactivated and the patient is under palliative care.

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.

• Brand Name: EASYTRAK 2 IS-1
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8712569
• MDR Text Key: 148437359
• Report Number: 2124215-2019-11102
• 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: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/21/2008
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 90 YR