MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VITALITY; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number T135

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 09/02/2014

Event Type  Injury  

Event Description

Boston scientific received information that this product was part of a system revision due to infection.It was noted that there was vegetation on the lead and the patient had sepsis.There were no additional adverse effects reported.The product was explanted.

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: VITALITY
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4398421
• MDR Text Key: 5122831
• Report Number: 2124215-2014-21604
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2006
• Device Model Number: T135
• Other Device ID Number: VITALITY DS VR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2005
• 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
• Treatment: T135; 0147
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR