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

Model Number 4542

Device Problems Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Defective Device (2588); High Capture Threshold (3266)

Patient Problem No Code Available (3191)

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Based on the event details, 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 (subclavian) 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.

Event Description

It was reported that this left ventricular (rv) lead had alleged insulation damage near the suture sleeve and a conductor fracture.This damage resulted in high, out of range pacing impedance measurements (>3000 ohms), high threshold measurements, and noisy signals.The physician elected to surgically utilize a lead repair kit on the lv lead and the sensing mode was reprogrammed to unipolar sensing to resolve the event.The lv lead remains implanted and in-service.The patient was stable with no additional adverse consequences.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; RQ 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11182567
• MDR Text Key: 227500322
• Report Number: 2124215-2020-28156
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410901
• UDI-Public: 00802526410901
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2019
• Device Model Number: 4542
• Device Catalogue Number: 4542
• Device Lot Number: 309413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention