MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND VITALITY 2; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number T175

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Ventricular Fibrillation (2130)

Event Date 12/28/2016

Event Type  Injury  

Manufacturer Narrative

This icd has been returned back from the field for analysis.This report will be updated upon completion of analysis.

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) delivered an inappropriate shock due to atrial fibrillation which accelerated the patient¿s rhythm into ventricular fibrillation and led to the delivery of additional shocks which eventually exhausted therapy in the icd.During this time the icd declared end of life as a result of a charge time of greater than 30 seconds.Surgical intervention was performed and the icd was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a review of device memory revealed that the device declared end of life (eol) after experiencing one charge time greater than 30 seconds.The observed rate of battery usage was compared to the expected rate of battery usage; the results indicated that the monitoring voltage was normal.Although the battery itself had not depleted prematurely, eol was triggered earlier than expected by extended charge times, and the eri to eol time period was shortened, due to a higher-than-typical build-up of internal battery impedance.

• Brand Name: VITALITY 2
• 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 ; 6515824786
• MDR Report Key: 6250529
• MDR Text Key: 64775085
• Report Number: 2124215-2017-00521
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/25/2010
• Device Model Number: T175
• Other Device ID Number: VITALITY 2 VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2009
• 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: 0148; 1646T; 1860; D141; T175
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR