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

Model Number 4543

Device Problems Fracture (1260); Defective Device (2588); Material Integrity Problem (2978)

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

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, an evaluation of this lead was performed.The lead was returned in two segments, but the tip section was missing.Based on the finding of lead tip missing and tears in the insulation, this was likely explant damage.Based on the of the finding of fractured conductors likely mid-section of lead body.Fracture was a non specific fracture mode.Laboratory analysis confirmed the reported allegation.

Event Description

It was reported that this left ventricular (lv) lead had physical damage on the insulation and lead body.The lead also had a lead conductor fracture which was verified though x-ray and fluoroscopy.Subsequently, this lead was explanted.No additional 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
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; #12, rd. #698; dorado PR 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12218428
• MDR Text Key: 263171780
• Report Number: 2124215-2021-20979
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526410994
• UDI-Public: 00802526410994
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2021

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: 03/08/2008
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 07/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2006
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR