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); Fracture (1260); High impedance (1291)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this left ventricular (lv) lead exhibited a sudden jump in pace impedance measurements from 1,000 ohms to greater than 3,000 ohms.The patient was seen for in-office lead testing, and non-capture and out-of-range pace impedance measurements were observed on all vectors using the tip electrode.No noise was observed, however the field representative did not do isometrics or pocket manipulation.Lead fracture was suspected.The lv lead was programmed ring to can, and will continue to be monitored at this time.This 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
• 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: 18735777
• MDR Text Key: 336631735
• Report Number: 2124215-2024-09823
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): Y
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/03/2008
• Device Model Number: 4543
• Device Catalogue Number: 4543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female