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

Model Number 4538

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930); Pocket Erosion (2013); Sepsis (2067)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to infection with sepsis.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The lv lead was explanted.

Manufacturer Narrative

This supplemental report is being filed to capture the pertinent information of a new patient code added to h6.

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to infection with sepsis.The patient was treated with intravenous antibiotics.There were no additional adverse patient effects reported.The lv lead was explanted.Additional information received indicates that the device was protruding under the armpit, had buildup of pus and was red and inflamed.There were no additional adverse patient effects reported.

• Brand Name: EASYTRAK LVA
• 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: 12661892
• MDR Text Key: 277345754
• Report Number: 2124215-2021-30388
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2005
• Device Model Number: 4538
• Device Catalogue Number: 4538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/19/2021
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2003
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male