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Impact of Medtronic’s Fidelis ICD Lead Recall

A Survey of Fifty-two Electrophysiologists

October 2007

Study Description

Topic

Reactions to Medtronic’s October 15, 2007 recall of its Fidelis implantable cardioverter defibrillator (ICD) leads

Respondent Type

Physicians

Specialties Covered

Electrophysiology

Region

United States Only

Methodology

Online survey, self-administered via a Panel Intelligence website

Duration: 15 minutes                

Size: 52

Fielding Dates: October 29, 2007 to October 30, 2007

Objectives

To understand and quantify the impact of Medtronic’s October 2007 recall of its Sprint Fidelis family of ICD leads by surveying a set of U.S.-based electrophysiologists.

§    Anticipate trends in ICD usage this quarter and over the next one to 5 years.

§    Estimate ICD brand shares pre- and post-recall.

§    Determine drivers of change in initial ICD implant volumes.

§    Understand impact of recall on physician perceptions of Medtronic.

§    Identify clinical implications of recall in terms of replacement leads used and explantation practices.

§    Determine impact, if any, of recall on usage of remote patient monitoring systems.

Companies and Products Mentioned in This Report 

Company

Ticker Symbol

Product(s)

Medtronic

MDT

Sprint Fidelis, Carelink, Quattro

St. Jude Medical, Inc.

STJ

Riata, Housecall

Boston Scientific Corp.

BSX

Reliance, Latitude

Biotronik

[Private]

None mentioned [limited coverage]

Inclusion Criteria and Respondent Demographics

Inclusion Criteria

 

§    Board-certified electrophysiologist

§    In practice between 2 and 30 years

§    Spends at least 75% of professional time in clinical practice

§    Performs at least 10 ICD implants per month

 

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