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

Model Number 4543

Device Problems Failure to Capture (1081); High impedance (1291); Defective Device (2588); Device Sensing Problem (2917)

Patient Problems Pulmonary Edema (2020); No Consequences Or Impact To Patient (2199)

Event Date 09/01/2018

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

Boston scientific received information that this left ventricular (lv) lead was not working.To date, the lv lead remains in service.No adverse patient effects were reported.

Event Description

It was also reported that this left ventricular (lv) lead exhibited high pacing impedance greater than 2000 ohms and was noted to have noise and loss of capture.The lv lead was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this lead was confirmed to be fractured 543 mm from the terminal pin.Based on the analysis results, we suspect that fatigue or stress in the region of the fracture site due to relative motion between the suture sleeve and an anatomical feature led to the fracture.As a lead moves in response to normal heart rhythms and blood flow, extensive flexing over a period of time may cause fatigue or stress, weakening the coil, ultimately resulting in a fracture.This can occur between the suture sleeve and some other part of the anatomy.Fatigue fractures in the pocket or clavicular/first rib area are well known and documented in the industry.A combination of lead design, implant techniques, and patient anatomy and activity level contribute to these types of occurrences.Evaluation method code, evaluation result code, evaluation conclusion code.

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was also reported that this left ventricular (lv) lead exhibited high pacing impedance greater than 2000 ohms and was noted to have noise and loss of capture.The lv lead was explanted.No additional adverse patient effects were reported.Boston scientific received information that this left ventricular (lv) lead was not working.To date, the lv lead remains in service.No adverse patient effects were reported.

• 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: 8588742
• MDR Text Key: 144411617
• Report Number: 2124215-2019-09419
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• 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,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2016
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Device Lot Number: 303176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR